Taking Statins May Boost Heart Surgery Outcomes.


Heart surgery patients taking statins should keep taking those cholesterol-lowering drugs, even on the day of their operation, because doing so may improve their chances of survival, a new study suggests.

“Based on our findings, we would advise patients to continue taking their statin medication all the way up to and including the day of surgery,” said study author Dr. Wei Pan.

Statins are one of the most widely prescribed drugs in the United States. One in four Americans 40 or older takes a statin, according to the U.S. Centers for Disease Control and Prevention.

In the new study, Pan’s team looked at more than 3,000 patients who underwent coronary artery bypass graft surgery. Pan is a cardiovascular anesthesiologist at the Texas Heart Institute in Houston.

The findings showed that the rate of death from all causes within 30 days was about 2 percent for those who took statins 24 hours or less before their operation.

In those who took statins 24 to 72 hours before their operation, the rate of death was nearly 3 percent. And, for those who never took statins or who took statins more than 72 hours before the surgery, the death rate was just under 4 percent, the researchers said.

The study was published online March 16 in The Annals of Thoracic Surgery.

“Patients frequently forget to take their pills on the day of surgery, or they’ve been told to stop certain medications,” Pan said in a journal news release.

“This study shows that not taking your statin for even one day before cardiac surgery may increase your risk of death after surgery,” he said.

“Statins are ubiquitous today, so this study is especially important as it highlights that a patient simply adhering to his or her already prescribed statin medication and not stopping it prematurely could be lifesaving,” Pan said.

The researchers noted that they believe this is the first study to look specifically at the timing of statin medication before surgery.

Dr. Todd Rosengart is a cardiothoracic surgeon at Baylor College of Medicine in Houston who wasn’t involved in the study.

He said in the news release that “this is an important study that clearly extends our understanding of the growing importance of statins in benefiting patients with cardiovascular disease.”

Although the study found a link between regular statin use and increased survival rates in these patients, it did not prove a cause-and-effect relationship.

Source:www.drugs.com

Physician Invents Reconstructive Surgery For Female Genital Mutilation.


There is new hope for the hundreds of millions of women worldwide who have been subjected to genital mutilation.

A surgeon in Penn Medicine’s Center for Human Appearance has developed a reconstructive procedure that can increase sexual function and, patients’ early experiences suggest, help heal the emotional and psychological wounds associated with the mutilation. Ivona Percec, an assistant professor of Surgery in the division of Plastic Surgery, reports on her use of the technique in three patients this month in the Aesthetic Surgery Journal. She also calls for greater awareness of this human rights issue in support of women who’ve suffered these experiences across the world.

 “Plastic surgeons have a crucial role to play in this recovery, and it’s important for physicians to be informed and prepared to address the surgical and emotional needs of women who seek care for this,” Percec said. “Our procedure is simple yet effective and can help victims restore their physical and psychological sense of well-being.”

The World Health Organization (WHO) defines Female Genital Mutilation (FGM) as, “any procedure that intentionally alters or causes injury to female genital organs for non-medical reasons and with no health benefits.” An estimated 200 million women have been subjected to FGM around the world, usually between the first week of life and adolescence, and often by their caregivers. It is a cultural ritual in parts of Africa, the Middle East, and Asia to encourage female sexual fidelity. It is internationally recognized as a violation of human rights.

FGM can also have long-term consequences, including severe pain, post-traumatic stress disorder, cysts, recurrent infections, and even death.

All three women were between the ages of 30 and 33 and had recently immigrated to the United States from Sierra Leone. In each case, the women were married but had not told their husbands they had undergone FGM as children.

“These women were embarrassed that they were subjected to this procedure, in particular since relocating to the United States,” Percec said. “All of them were able to have intercourse, but without pleasure – usually with pain.”

The patients wanted to know if there were any surgical options available to help them look and feel more normal. After Percec’s research turned up little in the way of established procedures, she used her knowledge of other reconstructive techniques in hopes of restoring appearance and function.

With an average follow up of almost a year, all three patients reported improved sexual function and decreased embarrassment with their partners. All three women said they would recommend this procedure to others who have suffered FGM.

“Female genital mutilation is a violation of the basic rights of women and children,” Percec said. “As nations around the world work to eliminate this custom, plastic surgeons can play an important role in the physical, emotional, and psychological recovery of women everywhere.”

ECSPECT prospective multicentre registry for single-port laparoscopic colorectal procedures


Abstract

Background

The international multicentre registry ECSPECT (European Consensus of Single Port Expertise in Colorectal Treatment) was established to evaluate the general feasibility and safety of single-port colorectal surgery with regard to preoperative risk assessment.

Methods

Consecutive patients undergoing single-port colorectal surgery were enrolled from 11 European centres between March 2010 and March 2014. Data were analysed to assess patient-, technique- and procedure-dependent parameters. A validated sex-adjusted risk chart was developed for prediction of single-port colorectal surgery-related conversion and complications.

Results

Some 1769 patients were enrolled, 937 with benign and 832 with malignant conditions. Procedures were completed without additional trocars in 1628 patients (92·0 per cent). Conversion to open surgery was required in 75 patients (4·2 per cent) and was related to male sex and ASA fitness grade exceeding I. Conversions were more frequent in pelvic procedures involving the rectum compared with abdominal procedures (8·1 versus 3·2 per cent; odds ratio 2·69, P < 0·001). Postoperative complications were observed in a total of 224 patients (12·7 per cent). Independent predictors of complications included male sex (P < 0·001), higher ASA grade (P = 0·006) and rectal procedures (P =0·002). The overall 30-day mortality rate was 0·5 per cent (8 of 1769 patients); three deaths (0·2 per cent; 1 blood loss, 2 leaks) were attributable to surgical causes.

Conclusion

The feasibility and safety, conversion and complication profile demonstrated here provides guidance for patient selection.

Introduction

Laparoscopic colorectal surgery is well established as an alternative to conventional open resection, and has been shown to be associated with short-term benefits, including earlier postoperative recovery, decreased postoperative pain, reduced impairment of pulmonary function and shorter hospital stay[1, 2]. Minimally invasive laparoscopic colorectal surgery is conventionally performed using several trocar sites and a separate incision for specimen extraction (multiport laparoscopic colorectal surgery). However, each incision has the potential for bleeding, haematoma, infection and incisional hernia. Single-port colorectal surgery has been used in recent years for both benign and malignant colorectal surgery[3-5]. Nevertheless, despite the potential advantages of single-port colorectal surgery, any innovative technique requires evaluation of its feasibility and safety before gaining wider acceptance[6]. To date, the literature on single-port colorectal surgery is limited to small case series and comparative studies. Furthermore, indications and preoperative selection criteria for the single-port colorectal surgery technique remain unclear, and risk factors for conversions and complications have not been established. Therefore, a multi-institutional European study group (ECSPECT) was established to assess the risk and safety of single-port colorectal surgery.

Methods

The objective of this study was to evaluate the safety and feasibility of single-port colorectal surgery. Thus, particular efforts were made to assess risk and complications, with the further objective of developing a complication risk chart. All surgical procedures were performed primarily using single-port access with only one abdominal incision. Use of any additional trocar was registered but not considered a complication itself. Intraoperative complications were defined as unintentional events that required deviation from the standard technique.

Procedures were classified as proximal or distal abdominal surgery, with the proximal category including right and left colonic resections, and distal incorporating all those with pelvic dissection for rectal resection, abdominoperineal resection (APR) and restorative proctocolectomy.

Postoperative complications were graded according to the Dindo–Demartines–Clavien classification[7]. An anastomotic leak was defined by: radiological demonstration of contrast extravasation; diffuse peritonitis with the presence of faecal fluid at reoperation; presence of a local abscess in the vicinity of the anastomosis; or faecal discharge from the drain or wound[8]. Operative mortality was defined as death from any cause during or after surgery within 30 days if the patient was discharged from hospital, or within any interval if the patient was not discharged.

Data collection

The local institutional review board for clinical trials approved the study and all patients gave informed consent. The clinical effectiveness committees of the participating centres considered this technique to be a formal laparoscopic method. To limit bias owing to heterogeneous learning curves, one surgeon responsible for the colorectal programme in each centre had performed more than 100 single-port colorectal surgery procedures before enrolment. Procedure numbers varied in relation to the preferences for the single-port approach in each centre. Five centres predominantly included patients with left-sided colectomies, whereas two centres mainly performed right colonic resections. Lower single-port procedures such as restorative proctocolectomy, rectal resections and APR were performed in seven of the 11 centres. The hospital data and records included medical notes and operating reports for all hospital admissions, and included patient-, technique- and procedure-dependent variables. All data were blinded and monitored by independent investigators. Data were then entered into the ECSPECT registry system, based on Microsoft Access® (Microsoft, Redmond, Washington, USA), by local study assistants who were unaware of patient identities. Patients were seen at an outpatient clinic 1 month after surgery, or had telephone interviews with study assistants. As such, the 30-day follow-up was 100 per cent complete.

Statistical analysis

In this prospective observational study, potential risk factors were investigated by means of univariable analyses; Fisher’s exact test and χ2 test were used for categorical variables, and the Wilcoxon rank-sum test or Kruskal–Wallis test for continuous variables. A univariable logistic regression analysis was also performed. Multivariable logistic regression models were fitted for conversion and complication as dependent variables. A risk score based on the estimated conversion and complication probabilities was devised: low risk corresponded to an estimated probability below the median for the patient group considered; moderate risk was scored between the median and the 90 per cent quantile and high risk above the 90 per cent quantile. Statistical analyses were carried out using R software version 3.0.3 (http://www.r-project.org). All statistical assessments were two-sided and a significance level of 0·050 was used.

Results

The ECSPECT registry includes data on 2032 consecutive patients who underwent single-port colorectal surgery between March 2010 and March 2014 at 11 centres in Austria, Denmark, Germany, Italy, the Netherlands, Spain, Switzerland and the UK. The surgical procedures (single-port colorectal surgery as a proportion of the total number of colorectal procedures) were performed in Leverkusen (638 of 1070), Salzburg (360 of 613), Turin (263 of 490), Varese (173 of 265), Bristol (145 of 310), St Gallen (142 of 451), Seville (109 of 210), Vienna (81 of 132), Amsterdam (49 of 130), Copenhagen (39 of 765) and Bremerhaven (33 of 114). Reasons for non-eligibility for single-port colorectal surgery were: cT4 tumours, bulky lymph nodules attached to vital pedicles (such as superior mesenteric vein in right colectomies), emergency procedure, or non-availability of the surgeon experienced in single-port colorectal surgery. The complete data were registered in a central database. A random group of 263 patients was excluded before any analysis and used as internal validation for the risk charts, leaving 1769 complete data sets as the study group for review and analyses.

Demographic characteristics according to the single-port procedures performed are shown in Table 1. As expected, sex differences were found between proximal procedure types without rectal involvement (right and left colectomies) and distal abdominal procedures (restorative proctocolectomy, APR and rectal resections). Younger patients were more likely to undergo restorative proctocolectomy or left colonic resections (Fig. S1a, supporting information), probably a result of the higher rates of inflammatory bowel disease in this cohort. There were no differences in distribution of ASA grades for proximal versus distal procedures: 25·5 versus 22·5 per cent ASA I, 54·3 versus 59·7 per cent ASA II, 18·7 versus 16·5 per cent ASA III, and 0·4 versus 0·5 per cent ASA IV, respectively (P = 0·297). However, among patients with ASA III and IV the single-port approach was used more often for right colonic resections than for all other procedures (Fig. S1b, supporting information). In contrast to left colectomies and restorative proctocolectomies, right colectomies, rectal resections and APR were performed significantly more often for malignancies. The histopathological staging of the malignant disease is shown in Table 2.

Table 1. Demographic data for patients who underwent single-incision laparoscopic surgery, in total and according to surgical procedure
Total Right colectomy Left colectomy Rectal resection Abdominoperineal resection Restorative proctocolectomy
(n = 1769) (n = 519) (n = 868) (n = 214) (n = 48) (n = 120) P
  • Values in parentheses are percentages unless indicated otherwise;
  • *values are mean(s.d.) (range).
  • χ2 test, except
  • Kruskal–Wallis test.
Age (years)* 61·1(14·4) 64·5(15·5) 60·2(12·2) 62·7(12·9) 65·9(13·3) 48·6(18·5) < 0·001
(13–93) (13–92) (21–89) (22–93) (23–88) (17–90)
Sex ratio (F : M) 913 : 856 275 : 244 465 : 403 100 : 114 16 : 32 57 : 63 0·026
BMI (kg/m2)* 26·0(4·6) 25·9(4·8) 26·4(4·6) 25·7(4·5) 25·2(4·0) 25·4(5·1) 0·020
(15–52) (16–52) (15–47) (17–48) (16–36) (16–45)
ASA fitness grade
I 439 (24·8) 132 (25·4) 221 (25·5) 62 (29·0) 3 (6) 21 (17·5) 0·005
II 981 (55·5) 242 (46·6) 511 (58·9) 112 (52·3) 38 (79) 78 (65·0) < 0·001
III 323 (18·3) 133 (25·6) 127 (14·6) 36 (16·8) 7 (15) 20 (16·7) < 0·001
IV 8 (0·5) 6 (1·2) 0 (0) 2 (0·9) 0 (0) 0 (0) 0·011
Not assessed 18 (1·0) 6 (1·2) 9 (1·0) 2 (0·9) 0 (0) 1 (0·8)
Disease type < 0·001
Benign 937 (53·0) 170 (32·8) 644 (74·2) 29 (13·6) 2 (4) 92 (76·7)
Malignant 832 (47·0) 349 (67·2) 224 (25·8) 185 (86·4) 46 (96) 28 (23·3)
Table 2. Tumour staging in patients with malignancy
Total Right colectomy Left colectomy Rectal resection Abdominoperineal resection Restorative proctocolectomy
(n = 832) (n = 349) (n = 224) (n = 185) (n = 46) (n = 28) P
  • Values in parentheses are percentages followed by standardized residuals unless indicated otherwise;
  • *values are mean(s.d).
  • χ2 test, except
  • Kruskal–Wallis test.
Tumour category < 0·001
ypT0/pTis 54 (6·5) 34 (9·7) 6 (2·7) 8 (4·3) 2 (4) 4 (14)
(3·24) (–2·71) (–1·36) (–0·61) (1·70)
pT1 125 (15·0) 34 (9·7) 49 (21·9) 24 (13·0) 5 (11) 13 (46)
(–3·62) (3·36) (–0·89) (–0·81) (4·73)
pT2 194 (23·3) 74 (21·2) 40 (17·9) 53 (28·6) 22 (48) 5 (18)
(–1·23) (–2·26) (1·94) (4·04) (–0·70)
pT3 451 (54·2) 203 (58·2) 128 (57·1) 98 (53·0) 17 (37) 5 (18)
(1·95) (1·03) (–0·38) (–2·42) (–3·93)
pT4 8 (1·0) 4 (1·1) 1 (0·4) 2 (1·1) 0 (0) 1 (4)
(0·46) (–0·92) (0·19) (–0·69) (1·44)
Node category 0·031
pN0 409 (49·2) 172 (49·3) 129 (57·6) 71 (38·4) 20 (43) 17 (61)
(0·06) (2·95) (–3·33) (–0·79) (1·24)
pN1 160 (19·2) 68 (19·5) 45 (20·1) 30 (16·2) 13 (28) 4 (14)
(0·16) (0·38) (–1·18) (1·60) (–0·68)
pN2 83 (10·0) 43 (12·3) 17 (7·6) 22 (11·9) 1 (2) 0 (0)
(1·92) (–1·39) (0·99) (–1·82) (–1·79)
Not assessed 180 (21·6) 66 (18·9) 33 (14·7) 62 (33·5) 12 (26) 7 (25)
(–1·62) (–2·93) (4·45) (0·75) (0·44)
No. of nodes retrieved* 18·00(8·55) 16·53(9·64) 16·74(9·61) 17·58(7·34) 15·07(6·17) 8·37(15·60) 0·133
Metastasis category < 0·001
pM0 614 (73·8) 266 (76·2) 181 (80·8) 136 (73·5) 23 (50) 8 (29)
(1·35) (2·79) (–0·10) (–3·78) (–5·54)
pM1 100 (12·0) 28 (8·0) 29 (12·9) 25 (13·5) 12 (26) 6 (21)
(–3·01) (0·50) (0·71) (3·02) (1·56)
Not assessed 118 (14·2) 55 (15·8) 14 (6·3) 24 (13·0) 11 (24) 14 (50)
(1·11) (–3·98) (–0·53) (1·95) (5·53)

Surgical techniques

Disposable ports used for single-port laparoscopic procedures included: SILS-Port™ 56·5 per cent (Covidien-Medtronic, Dublin, Ireland); GelPort® 23·4 per cent (Applied Medical, Rancho Santa Margarita, California, USA); OctoPort™ 6·0 per cent (DalimSurgNET, Seoul, Korea); TriPort™ 2·2 per cent and QuadPort™ 0·1 per cent (Advanced Surgical Concepts, Wicklow, Ireland); and S.P.I.D.E.R. 0·1 per cent (TransEnterix®, Research Triangle Park, North Carolina, USA). Alternatively, reusable trocars were employed, namely: Storz X-Cone™ 7·9 per cent (Karl Storz, Tuttlingen, Germany); multiple trocars 3·6 per cent; homemade glove trocar 0·2 per cent; or KeyPort™ 0·1 per cent (Richard Wolf, Knittlingen, Germany). The incision was made routinely at the umbilical groove, except when a protective ileostomy was planned after rectal resection. Three patients (0·2 per cent) had a suprapubic incision via pre-existing scars. Fascial and skin closure was according to the preference of the surgeon. Pre-existing hernias were closed directly without the use of prophylactic mesh. In all procedures extra-long optical devices were used. Surgeons predominantly used straight working instruments (62·2 per cent) followed by curved instruments (37·8 per cent). Suspension devices were used in 160 patients (9·0 per cent) to improve exposure of the surgical field, including sutures in 143 (8·1 per cent), lifting devices in 14 (0·8 per cent) and magnets in three (0·2 per cent). The main indication for use of a suspension device was to place tension on the ileocolic segment in right hemicolectomy (19·1 per cent) or to elevate the uterus or bladder in APR (25·0 per cent) or rectal resection (6·1 per cent). No additional suspension was considered necessary in other procedures (1609, 91·0 per cent). Anastomoses were performed intracorporeally (1304, 73·7 per cent) and extracorporeally (390, 22·0 per cent); 75 patients (4·2 per cent) required no anastomosis. Extracorporeal stapling was the method of choice in right colectomy (73·0 per cent). All other procedures favoured either intracorporeal stapling (left colectomy 98·3 per cent, rectal resection 93·5 per cent, restorative proctocolectomy 92·5 per cent) or no anastomosis (note that 1 anastomosis in the APR group was performed elsewhere in the colon).

Technical results

A total of 1628 procedures (92·0 per cent) were completed without any additional trocar. One, two and three supplementary trocars were used in 121 (6·8 per cent), 17 (1·0 per cent) and three (0·2 per cent) procedures respectively. There was a trend towards use of more trocars in distal procedures with rectal resection (Fig. 1a) and in patients with higher BMI (Fig. 1b). Operating times differed significantly for right colectomy (mean(s.d.) 124(48) min), left colectomy (157(58) min), rectal resection (183(90) min), APR (305(76) min) and restorative proctocolectomy (197(108) min) (P < 0·001) (Fig. S2, supporting information). The duration of operation was prolonged in transrectal retrieval compared with that in the centre-matched cohort of patients undergoing rectal resections via an abdominal retrieval site (239·0(103·7) versus185·1(73·4) min; P = 0·014). In centres performing both types of anastomosis, operating times for right-sided colectomies with intracorporeal and extracorporeal anastomoses were not significantly different (123·0(47·4) versus 133·0(49·7) min; P = 0·057). Specimen retrieval was performed using a wound protector, a retrieval bag, or both, in all patients. Most specimens were removed via the primary incision, including APR (via the perineal incision) (Table 3). In left-sided colectomy and rectal resection, neither operating times nor complications were different between transvaginal and/or transrectal specimen retrieval routes. Predictors for prolonged operation were BMI (P = 0·005, univariable analysis), and ASA grade exceeding I, male sex, distal procedure, conversion, use of non-curved instruments, use of additional trocars and transrectal retrieval site (P < 0·001, multivariable regression analysis).

Correspondence analysis showing procedures (PC, restorative proctocolectomy; APR, abdominoperineal resection; rectal, rectal resection; left, left colectomy; right, right colectomy) in relation to need for additional trocars. b Box plots showing BMI in relation to need for additional trocars. Median value (bold line), interquartile range (box), and range (error bars) excluding outliers (symbols) are shown. P = 0·005 (Kruskal–Wallis test)
Table 3. Specimen retrieval site for single-incision laparoscopic colorectal procedures
Total Right colectomy Left colectomy Rectal resection Abdominoperineal excision Restorative proctocolectomy
(n = 1769) (n = 519) (n = 868) (n = 214) (n = 48) (n = 120)
  1. Values in parentheses are percentages.
Primary incision 1624 (91·8) 515 (99·2) 800 (92·2) 189 (88·3) 0 (0) 120 (100)
Transvaginal 44 (2·5) 3 (0·6) 39 (4·5) 2 (0·9) 0 (0) 0 (0)
Transrectal 41 (2·3) 0 (0) 28 (3·2) 13 (6·1) 0 (0) 0 (0)
Transperineal 48 (2·7) 0 (0) 0 (0) 0 (0) 48 (100) 0 (0)

Conversion

Some 1694 single-port colorectal surgery procedures (95·8 per cent) were completed without conversion. The reasons for conversion were anticipated operative difficulty (pre-emptive, strategic conversions: 68, 91 per cent) or intraoperative complications and technical problems after more than 15 min (reactive conversions: 7, 9 per cent). Conversion rates and independent predictors for conversion are shown in Table 4. BMI differed significantly among patients undergoing procedures with and without conversion (mean(s.d.) 26·0(4·6) versus 28·0(4·9) kg/m2; P < 0·001).

Table 4. Converted procedures and results of multivariable logistic regression analysis to identify independent predictors of conversion
No. of conversions Odds ratio P
  1. Values in parentheses are percentages.
Procedure
Right colectomy 17 (3·3)
Left colectomy 27 (3·1)
Rectal resection 19 (8·9)
Abdominoperineal resection 4 (8)
Restorative proctocolectomy 8 (6·7)
Procedure location
Proximal 44 (3·2) 1·00 (reference)
Distal 31 (8·1) 2·69 < 0·001
Sex
F 23 (2·5) 1·00 (reference)
M 52 (6·1) 2·50 < 0·001
ASA grade
I 5 (1·1) 1·00 (reference)
> I 70 (5·3) 4·89 < 0·001

Complications

Intraoperative complications were observed in 29 patients (1·6 per cent), and included bleeding (13), injury to the urinary tract (7), enterotomy (5) and splenectomy (owing to laceration, 1). In seven of these patients the operation was converted to open surgery. More patients with malignancies had intraoperative complications than those with benign underlying disease (20 versus 9 patients; odds ratio 2·53, P = 0·023). Most of the intraoperative complications were seen in right colonic resections (16 of 29). The use of additional trocars was different in patients with and without intraoperative complications (28 versus 7·6 per cent; odds ratio 4·60, P = 0·001). Interestingly, extracorporeal anastomosis was performed in nearly all patients with complicated right colonic resections (15 of 16 patients).

Postoperative complications were observed in 224 patients (12·7 per cent) (Table 5) and were unrelated to conversion to laparotomy.

Table 5. Complications and results of multivariable logistic regression analysis to identify independent predictors of complications
Postoperative complication SSI Anastomotic leak Odds ratio P
  • Values in parentheses are percentages.
  • *Dindo–Demartines–Clavien classification. SSI, surgical-site infection.
Complication grade*
I 66 (29·5)
II 40 (17·9)
III 73 (32·6)
IV 37 (16·5)
V 8 (3·6)
Procedure 0·008
Right colectomy 68 (13·1) 38 (7·3) 29 (5·6)
Left colectomy 89 (10·3) 5 (0·6) 28 (3·2)
Rectal resection 35 (16·4) 1 (0·5) 5 (2·3)
Abdominoperineal resection 9 (19) 0 (0)
Restorative proctocolectomy 23 (19·2) 2 (1·7) 1 (0·8)
Procedure location
Proximal 157 (11·3) 1·00 (reference)
Distal 67 (17·5) 1·67 0·002
Sex
F 91 (10·0) 1·00 (reference)
M 133 (15·5) 1·66 < 0·001
ASA grade
I–II 167 (11·8) 1·00 (reference)
III–IV 57 (17·2) 1·56 0·006
Disease type
Benign 104 (11·1) 1·00 (reference)
Malignant 120 (14·4) 1·35 0·038

Sex-adjusted risk charts for preoperative prediction of conversion and complication

Based on univariable risk analyses and logistic multivariable regression modelling to determine predicted probabilities for given patients’ profiles (scores), risk charts were developed for the prediction of conversion (Fig. 2) and complication. According to the median and 90 per cent quartile of the predicted probabilities for conversion, patients’ profiles were classified into low, moderate and high risk. Neither age nor malignancy had significant influence on the conversion rate. Thus, the conversion risk chart (Table S1, supporting information) allows preoperative assessment of any possible conversion according to BMI, sex, procedural involvement of the rectum (distal procedures) and ASA grade. Similarly, risk scores were established to classify patients as low, moderate or high complication risk according to a cluster analysis. In particular, male sex, ASA grade III–IV and distal procedures were found independently to result in a higher risk of complications. The complication risk chart (Table S2, supporting information) allows preoperative risk assessment of any possible intraoperative and/or postoperative complication based on the adjusted classification. These scores were validated by enrolment of an additional group of 263 patients who had single-port colorectal surgery.

Violin plots showing conversion risk in relation to a sex, b ASA grade and c procedure location. Median value (symbol), interquartile range (bold line), range (error bars) and kernel density estimate (shaded area) are shown. d Predicted probability of conversion during the single-incision laparoscopic procedure as a function of BMI

Mortality

The overall 30-day mortality rate was 0·5 per cent (8 of 1769), comprising three deaths each following right colectomy and left colectomy, and one death each following rectal resection and restorative proctocolectomy. There were no deaths among patients undergoing APR. The cause of death was surgical in three patients (bleeding 1; multiple organ failure following anastomotic leak in 2 patients on postoperative days 11 and 25 respectively) and medical in five (myocardial infarction 3, pulmonary embolism 1, stroke 1).

Hospital stay

The mean(s.d.) length of hospital stay was 7·8(8·9) days for right colectomy, 8·6(5·4) days for left colectomy, 8·7(6·6) days for rectal resection, 19·0(19·6) days for APR and 10·0(6·7) days for restorative proctocolectomy. Only 54 patients were discharged within 24 h.

Discussion

The broad feasibility and safety profile of the single-port colorectal surgery technique endorses its general applicability. Sex-specific, validated conversion and complication risk charts were compiled to guide patient selection, and to inform decision-making and consent.

Natural-orifice transluminal endoscopic surgery (NOTES) was developed to avoid external incisions and scars altogether, but lacks overall acceptance and experience with colorectal procedures is still sparse[8-10]. Techniques providing natural-orifice specimen extraction via transvaginal or transrectal routes remain valid options[11]. Unlike NOTES, single-port colorectal surgery is a simple modification of conventional laparoscopic surgery that does not require novel instruments or specific new operative strategies, but can be performed by surgeons who are experienced with laparoscopic techniques. Since the first colorectal applications of the single-port colorectal surgery technique were introduced in 2008[4, 5], many clinical series have been published on benign and malignant indications[3, 12-19]. Studies comparing single-port with multiport surgical techniques have demonstrated similar results in terms of complications, blood loss, number of lymph nodes harvested, tumour resection margins, complications and hospital stay[20-23]. Although single-port colorectal surgery is considered more technically demanding, only four early studies[24-27] reported longer operating times for single-port colorectal surgery compared with multiport laparoscopic colorectal procedures. Given that the registry analysis was not designed as a randomized case–control study, the mean(s.d.) operating time of 158(73) min, which includes even the most complex procedures and an array of indications, falls within the mean times reported for single-port and multiport surgery (130–175 min)[22].

Although it was reported that operations can be performed with straight instruments and without the need for special additional equipment[17, 18], interestingly, the use of curved instruments was associated with a significant decrease in operating time in the present study. Possibly the more convenient triangulation led to fewer collisions and allowed a better operative view, thus avoiding repetition of ineffective retraction and dissection. All surgeons used a variety of ports and the present data do not suggest any preference. As expected, longer operating times were associated with higher BMI, use of additional trocars and postoperative complications. The low 30-day mortality rate here is similar to published data (0·5 per cent), demonstrating that mortality after single-port colorectal surgery is mostly related to medical conditions and complications associated with the underlying disease[20-23]. Postoperative complications (in 12·7 per cent of patients) were unrelated to conversion to laparotomy and, unsurprisingly, more frequent in procedures that included pelvic dissection than right or left colectomies. The incidence of anastomotic leakage of 3·7 per cent is comparable to rates of 0·9–6·7 per cent for single-port colorectal surgery reported in smaller series[18, 26, 28]. Although the overall incidence of anastomotic leakage was very low, leakage was associated with death in two patients.

In right colectomies, intracorporeal anastomoses and extracorporeal stapling were associated with similar operating times, but the former resulted in fewer intraoperative complications (in particular bleeding). This might be explained by more traction on the bowel, and more technical difficulty in exteriorizing the specimen through the umbilicus, especially in overweight patients[29]. Buchs and colleagues[30] reported an incidence of 3·6 per cent for anastomotic leakage, and identified rectal location, higher ASA score and prolonged operating times as predictors. However, the low incidence of anastomotic dehiscence for rectal procedures (compared with right or left colonic resections) in the present study could be due to selection bias (patients and/or surgeons). Hirabayashi and co-workers[31] emphasized the importance of surgeon experience in 258 consecutive colorectal cancer procedures.

The rate of wound complications was low (2·5 per cent during short-term follow-up), which is identical to previous data for single-port colorectal surgery[20, 32]. The data are further supported by reports of substantial benefits in wound complication rates in single-port colorectal surgery compared with multiport laparoscopic colorectal procedures in patients undergoing surgery for colorectal cancer (4·3 versus 13 per cent)[28], diverticular disease[33] or complex colorectal surgery[34]. In single-port colorectal surgery the transumbilical access does not necessitate muscle transection, thus reducing the risk of bleeding and subsequent haematoma. This, combined with the wound protection offered by the device itself, may be responsible for the low rate of wound complications in the present series. Data from Japan suggest a 19 per cent lower cost for single-port colorectal surgery in comparison to multiport laparoscopic colorectal surgery using commercial single ports[32]. It is possible that the reduced length of hospital stay[17] and reduction in instrument costs for single-port colorectal surgery may potentially lead to an economic advantage, but this was not addressed in the present investigation. This registry study is limited by its non-randomized design and short follow-up period of 30 days after surgery. The assessment of late complications and overall (oncological) outcomes was not an objective of this study.

The large number of surgeons and participating institutions emphasizes the value of this registry study in representing a real-life scenario and reducing selection bias. Increasing patient numbers and long follow-up are current objectives of the ECSPECT registry to provide continued robust evaluation of single-port colorectal surgery. Finally, only well conducted randomized trials will allow a definite conclusion regarding the technical superiority of single-port colorectal surgery over conventional laparoscopy.

ECSPECT single‐port laparoscopic colorectal procedures.


Laparoscopic colorectal surgery is well established as an alternative to conventional open resection, leading to earlier postoperative recovery, decreased postoperative pain and a shorter hospital stay. Conventionally, invasive laparoscopic colorectal surgery is performed as a multiport surgery, using several trocar sites and a separate incision for specimen extraction; but this has the disadvantage of each incision being a potential site of bleeding, hematoma, infection and incisional hernia, explain the authors of the present pan-European study. Single-port colorectal surgery would offer significant advantages in this respect, but the data on this approach is still insufficient. The multi-institutional European study group (ECSPECT) was established to assess the general feasibility and safety of single-port colorectal surgery, and to provide guidance for patient selection. The study included 1,769 patients (937 with benign conditions, 832 with malignant conditions).

4.2 % of patients required conversion to open surgery; conversions were more than twice as frequent in pelvic procedures involving the rectum than in abdominal procedures (8.1 versus 3.2 %; odds ratio 2.69, P < 0.001). Postoperative complications occurred in 12.7 % of patients, and independent predictors of complications included male sex (P < 0.001), higher ASA grade (P = 0.006) and rectal procedures (P = 0.002). The overall 30-day mortality rate was 0.5 %.

This study shows the broad feasibility and safety profile of the single-port colorectal surgery technique and therefore endorses its general applicability, conclude the authors. Patient selection should be guided by the sex of the patient and his or her risks for conversion and complication.

HOW DOES A PENIS TRANSPLANT WORK?


Doctors perform surgery together in Cambodia

Before the first penis transplant can be performed, doctors just need to find the right donor.

Soldiers give up a lot when they’re defending their country. For those who fall victim to snipers and explosives, and who survive, that could mean losing a limb or an organ or their sight. An often unspoken injury is the loss of genitalia. The wars in Iraq and Afghanistan, where roadside bombs are a constant threat, have left more than 1,300 American soldiers mangled in this way. But a team of doctors and scientists at Johns Hopkins Medicine is now ready to help—by performing the first penis transplant in the U.S. (Similar but less extensive procedures have been carried out in China on patients who lost parts of their penises in accidents and in South Africa to repair botched circumcisions).

There isn’t just one reason why penis transplants have taken so long to come about in the U.S. Part of it is probably that the transplant is still experimental–the patient in China had to get the procedure reversed after his body rejected the transplant. To many in the medical establishment, that’s an unnecessary risk for patients who have already undergone so much physical trauma—a patient’s life isn’t in danger if he doesn’t get a penis, as he would be if he needed a new liver or a kidney. Many doctors think restoring genitalia is medically (and ethically) wrong, that it’s not worth compromising the patient’s immune system for the rest of his life.

 Many doctors think it’s not worth compromising the patient’s immune system for the rest of his life.

Arthur Burnett, a urologist and director of the sexual medicine fellowship program at Johns Hopkins Medicine who is on the surgical team, and his colleagues, disagree. “We argue that these portions of people’s bodies need to be considered in a different light,” he says. “Many of these guys are 25 and their genitalia is gone. They just want to be whole again.”

Any day now, the Johns Hopkins team is prepared to implant a donor penis on a young soldier who lost his penis in an Afghan bomb explosion. What they’re waiting for is a donor, or specifically for the family of a newly deceased man (who has volunteered for organ donation) to approve the unorthodox procedure. Unlike other organ donations—which are meant to save lives—penis transplants are considered cosmetic and therefore optional. The donor, in addition to the usual transplant requirements like matching blood type, must also possess the same skin tone, and have been within five or 10 years of age of the recipient. Only then can the surgery proceed.

How will it work?

First, to be eligible for a transplant, a wounded solider must have intact pelvic bones—“Like a foundation for a house,” Burnett says. The first recipient meets this requirement, as do 60 other wounded veterans whom Johns Hopkins has approved for the surgery. None of them are eligible for reconstructive surgery in which the penis is rebuilt from tissue taken from elsewhere in the body, often from their forearms–they’ve lost too much tissue from the penis for doctors to rebuild it.

Once a donor is found, doctors have just a few hours to remove the man’s penis and pelvic muscles (matching the size of the wounded soldier’s pelvic area) and quickly transport it to the operating room. Burnett and a team of over 20 medical professionals will have already prepped the soldier, cutting away skin, scar and muscle and exposing dozens of blood vessels, nerves and the urethra, through which urine and semen flow. As in other organ transplants, surgeons must stitch all these to the donor’s tissues, but a penis transplant is more technically complex because the connections are so numerous and tiny. The procedure, according to one of the Johns Hopkins surgeons, will take about 12 hours.

Each of the 60 penis transplants that the hospital plans to perform will be unique, depending on the patient’s injury and his anatomy. Surgeons must remove the right amount of tissue from the donor’s abdomen to fill in what the recipient lacks. Testicles cannot be re-attached or fabricated. If an injured vet is missing testicles, he might need hormone replacement therapy to replace the testosterone they typically secrete. Further, the patient’s body might reject the transplant. To minimize that risk, he will receive an infusion of the donor’s bone marrow and will take immunosuppressants for the rest of his life.

Even then, there’s no guarantee the penis will be fully functional, especially when it comes to sex. “We hope we can reconstitute things in a way where men can get a true erection,” Burnett says. “But we might find that we’ve put everything back together and they might still not be getting quality erections. That may require some assistance, like Viagra, or some guys might have to come back to receive a penile prosthetic.” A penile prosthetic is an inflatable synthetic device surgically implanted in the chambers of the penis. A man with the implant can pump in fluid whenever he wants an erection. Burnett performs 80 of these implants every year in men who suffer erectile dysfunction.

What about the emotional impact?

Aside from the medical challenges, the psychological after effects of a penis transplant can be difficult. “We have to make sure that patients are ready to move forward, that they’re counseled well, that the patient is prepared to have his body reconstructed,” Burnett says. “It’s a change that might be hard for a patient or a spouse to accept sometimes. They’re having intercourse with another man’s penis, if you think about it.” To counter this, patients will need, and are required to undergo, psychological counseling before and after the surgery.

While the medical establishment seems to be reluctant to advocate for these procedures, the public tends to be understanding of these needs, Burnett has found. These men want to be fathers, to be intimate with their significant others. This operation can make that happen. If anything, their desire for the transplant is a testament to how much a human will do to feel normal again.

Burnett does not know if the donor for his first transplant will turn up in a few days or a few months. But his surgical team is ready–they’ve performed mock procedures on cadavers, Burnett says, and have done dry runs and rehearsals. “It could conceivably be very successful,” he says. He hopes that one day others in his field acknowledge the importance of this surgery, and that all 60 veterans who have signed up will get their transplants as soon as possible.

“Hopefully we’re going to move forward,” Burnett says. “I hope that, with this communication, even medical professionals will accept that this is something that’s meaningful to patients.”

What you need to know about those new, deadly heart-surgery infections



Coronary artery bypass surgery.

The Centers for Disease Control and Prevention warned open-heart surgery patients recently that they were at risk of a deadly infection linked to a medical device used during their operations. Now, worried consumers say they are having a hard time getting information from hospitals and doctors about what they should do.More than a half-million patients could have been exposed to bacteria that can cause serious illness or death. That’s the estimated number of patients who had open-chest surgery involving potentially contaminated equipment in the past several years. The bacteria are a type of nontuberculous mycobacteria, or NTM. Although infections are rare, experts are worried because patients may not develop symptoms or signs of infection for months, so diagnosis may be missed or delayed.

The device is a heater-cooler unit, which helps keep a patient’s circulating blood at a specific temperature during operations. It’s used in an estimated 250,000 surgeries in the United States every year, including cardiac bypass, valve replacement and  liver transplants. About 60 percent of these procedures use the German-made model that has been linked to the infections, the Stöckert 3T heater-cooler, made by LivaNova PLC, formerly Sorin Group Deutschland GmbH.

The CDC is advising hospitals to notify patients who had open-chest surgery involving these devices going back to Jan. 1, 2012. There is new information that indicates these devices were probably contaminated during manufacturing.

The Washington Post’s Lena H. Sun spoke with consumer advocates and health experts, including CDC’s Mike Bell, deputy director of health-care quality promotion, about what patients should do.

How do I know if I need to be worried?

If you’re not having symptoms, there’s nothing you need to do. But patients who have had open-heart surgery should seek medical care if they’re having nonspecific symptoms associated with infections, such as night sweats, muscle aches or pain, weight loss, fatigue or unexplained fever.

What if I don’t have symptoms but want to make sure my doctors know about this situation?

The CDC has a sample letter that patients can download, customize and take to their cardiologist or family doctor or whomever you see for ongoing medical care. The letter explains the risk of infection and CDC’s recommendation that clinicians consider NTM as a potential cause of unexplained chronic illness.

“Patients should say to their doctors, ‘I want you to put this in my file and be aware this could happen. If I start having infection symptoms, I want to be tested,’ ” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.

What if my open-chest surgery took place before Jan. 1, 2012?

The CDC’s Bell said the vast majority of infections flare up within four years of exposure. But regardless of when you had this type of surgery, if you are having symptoms, you should contact your health-care provider as soon as possible.

Are there any drugs I can take to prevent these infections?

Currently, there aren’t any safe prophylactic treatments.

Are these infections treatable?

Yes. A specific combination of antibiotics can treat NTM infections.

Why is the CDC worried about these devices?

Researchers have found that fans on these units may blow bacteria from inside the machine into the operating room. If the bacteria land on a heart valve that is about to be implanted or a surgical wound, it could cause an infection.

How many hospitals do this kind of operation in the United States?

An estimated 1,200 hospitals in the United States perform bypass operations, according to federal government sources.

What if my hospital used a different brand of heater-cooler?

These machines operate in similar ways. They could be contaminated in similar ways and also pose infection risk.

What is the risk of infection?

In hospitals where at least one infection has been identified and linked to the device in question, the risk was low, between 1 in 100 and 1 in 1,000. CDC officials say patients who had valves or other prosthetic implants are at higher risk.

How long does it usually take for these infections to show up?

It may take months and up to several years after the operation. Virtually all the cases reported so far in Europe and the United States have occurred within four years of surgery.

What are these bacteria? Can an infected person spread it to others?

NTM is common in water and soil. The bacteria rarely make healthy people sick. The danger arises when these bacteria enter the chest cavity or an open wound, especially in someone with a weakened immune system. The bacteria cannot be spread to others.

How many illnesses and deaths have been linked to these infections?

Between January 2010 and August 2016, the FDA received 91 reports from around the world about these devices. At least 79 were patient infections, with 55 in the United States. The infections include at least 12 deaths, including seven U.S. deaths. (In some cases, a report may describe a cluster of patients. In other cases, more than one report may be submitted from the same incident.)

Hospitals in Iowa, Michigan and Pennsylvania have reported infections.

Is there a test to know whether I’ve been exposed?

There is no such test. Infections can only be diagnosed by growing the bacteria in a lab. But that may take up to two months or longer. What’s more, getting the right kind of specimen depends on where the infection is. It could be in the blood, or it might show up in an infected wound.

“It has to be cultured under the right circumstance so the finicky bacteria will actually grow,” Bell said.

Why hasn’t my hospital notified me? There’s nothing on the website, and I can’t reach a person who knows anything.

Many patients say they’re frustrated by their inability to find out anything from the hospital where the operation took place. The hospitals have been getting alerts for the past year from the CDC and the Food and Drug Administration. But the CDC and FDA don’t have authority to require hospitals to notify patients. The American Hospital Association, an industry association, says it has advised its members to review and determine how best to follow the CDC recommendations. But Jay Bhatt, the AHA’s chief medical officer, said it takes time to review records and identify patients who might have been affected

How many of these Stöckert 3T heater-cooler devices are there? Why haven’t these devices been recalled?

As of July 2015, the company publicly reported there were 1,914 devices in health-care facilities around the world, including in the United States. In 2015, the company recalled the instructions for use, but not the device itself. The FDA imposed an import alert in December 2015. The devices are critical for lifesaving surgery, and a recall could result in many patients being harmed.

I’m supposed to have elective surgery to have a heart valve replaced. Should I postpone the surgery?

For nonemergency surgeries, patients might want to ask their doctors if they have the option of waiting for a little while, says CDC’s Bell. Patients should make sure their surgeons and hospitals disclose these risks, in writing, during the pre-surgery informed-consent discussions.

What are hospitals doing in the meantime?

Hospitals are working through the logistics involved in notifying patients.

“Facilities are not well set up to receive a large number of public calls,” said Bell. He said hospitals in Pennsylvania and Iowa that had clusters of infections had to set up a special telephone number to receive inquiries and guide people to the next step.

Hospital officials are also looking to find ways to minimize the risk of infection, such as keeping the devices outside the operating room, or looking for alternative machines that don’t have fans, Bell said.

“Every hospital is thinking about how to make this problem no longer exist,” he said.

 

Flawed and Poor-Quality Surgical Instruments Place Patients at Risk


The BBC documentary, “Surgery’s Dirty Secrets,” which originally aired in 2011, investigates the sources of surgical tools, and highlights flaws in British safety regulations.

Story at-a-glance

  • Surgeons need the right tools for the job, and these tools must be made to exact specifications and be of the highest quality. A BBC investigation reveals 20 percent of all surgical tools used fail to meet quality standards
  • Common defects include fractured and re-welded instruments, sharp protruding guide pins on forceps that can lacerate gloves, burs and metal fragments that can break off, corrosion and pitted metals
  • Two-thirds of the world’s surgical instruments are manufactured in Pakistan, although many are marked “Made in Germany” — either through a legal loophole or an illegal profit-boosting scheme

If you’re like most, you probably assume that surgical instruments are made to the very highest, exacting standards. The reality of where and how these tools are made is downright shocking.

According to BBC reporter Samantha Poling, who spent a year investigating this topic, there are significant problems in the industry — problems that can, and have, caused severe illness and death.

An estimated 30 million operations are carried out in British hospitals each year. In order to perform, surgeons need the right tools for the job, and these tools must be made to exact specifications and be of the highest quality.

Poorly made or non-functioning surgical tools can mean the difference between a successful surgery and the loss of a limb or organ, or death of the patient.

For example, for each fraction of a second a surgical assistant is struggling with a poorly functioning arterial clamp, the patient is losing blood, compromising the success of the surgery.

Lethal Infections Spread by Surgical Tools

In 2009, Dorothy Brown underwent heart surgery at Nottingham City Hospital. While the operation was a success, she contracted an antibiotic-resistant infection that nearly claimed her life. Ten other patients operated on by Brown’s surgeon around the same time contracted the same lethal infection.

Five of them subsequently died. In the U.S., the Food and Drug Administration (FDA) reports at least 1,000 incidences where poor-quality surgical instruments have caused harm each year.

A confidential report obtained by Poling reveals the two most likely causes of the mass infection at Nottingham City Hospital were either airborne bacteria or micropunctures in the surgeon’s gloves. As a result of the internal investigation, surgeons must now wear thicker gloves or double-up on regular gloves.

But what would repeatedly cause micropunctures in the surgeon’s gloves in the first place? According to experts, the most likely cause is poor-quality surgical instruments.

While few medical professionals were willing to go on record with the BBC, Tom Brophy, a lead technologist with Barts Health NHS (National Health Service) Trust, did. Deeply concerned about what he’s been seeing, he has started collecting evidence showing just how defective some surgical tools are.

Most of these defects cannot be seen with the naked eye, but under magnification, jagged edges and poor-quality construction becomes readily evident. Common problems reported by Brophy include:

  • Fractured and re-welded instruments, which can harbor and spread bacteria
  • Sharp, protruding guide pins on forceps that can lacerate gloves
  • Sharp burs and metal fragments that can break off, lacerating gloves and/or pose an infection risk if deposited inside the patient
  • Corrosion and pitted metals that can pose an infection risk
  • Faulty screw heads

1 in 5 Surgical Instruments Is Flawed

According to Brophy, 1 in 5 instruments, or about 20 percent of all instruments he receives, are rejected due to flaws that place patients’ health at risk. He even reports receiving used equipment where blood and dried tissue could pose an infection risk.

These tools are somehow recycled and passed off as brand new — something that simply should not occur. Yet it’s happening. Poorly constructed instruments also should not enter the surgical suite, yet they do with frightening frequency. How is all of this possible?

In the U.K., manufacturers and suppliers of surgical instruments must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA), and there are over 900 manufacturers registered.

In December 2010, following mounting complaints about shoddy quality, the agency issued a warning to all manufacturers saying steps must be implemented to ensure that all instruments are “fit for purpose.”

However, the responsibility for ensuring that quality standards are actually met still rests with the manufacturers, not the MHRA or any separate quality control agency. The suppliers are not even required to inspect the products received from the manufacturer before reselling them to a hospital.

In all, there are 180 health trusts and boards in the U.K., but Barts is the only health trust that actually employs a technologist to inspect all the instruments before they’re used in surgery.

Disturbingly, when Brophy sent back rejected instruments to an Asian supplier, he was told that the instruments were sent out to another U.K. hospital that accepted them without issue. “Well, of course they’re going to accept them,” Brophy says, “because they haven’t checked them.”

Where Are Surgical Tools Made?

Thoughts of Swiss-made precision come to mind when considering how surgical tools are made, but two-thirds of the world’s surgical instruments are actually manufactured in Sialkot, located in the northern Punjab area of Pakistan.

Seventy percent of the 900 surgical tool manufacturers registered with the MHRA are based there.

Some of these manufacturers appear to be doing a decent job, including Hilbro, which is one of the largest manufacturers. Each instrument is at least visually inspected with a magnifying glass before being sent out. Others operate under far more questionable circumstances.

Regal Medical Instruments, a small manufacturer in Sialkot that sends their wares to two small-scale suppliers in the U.K., offers a wholly different view of the industry. The facility is so dark you can barely see, and metal dust fills the air. Surgical instruments lie scattered in piles on the floor.

In their quality assurance department, employees visually inspect each instrument before stamping it with the requisite “CE” quality stamp required by the MHRA, but no magnifying glass is used. This means most defects caught by Brophy — who uses a microscope — will never ever be caught.

Then there’s “the ramshackle side to the industry,” to use Poling’s words. In this part of town, workers toil away at their grindstones in tiny dust-filled shacks with open sewers flowing past their doorways. According to Poling, larger, respectable companies frequently outsource work to these workers in order to meet demand.

In all, there are more than 3,000 of these “outsourcing units” in Sialkot, and these workers make less than $2.50 per day. According to some of the workers, both Hilbro and Regal Medical regularly buy surgical instruments from them.

‘Made in Germany’ — Not Quite!

Remarkably, the maker’s mark on these Pakistani-made tools will often say “Made in Germany.” As explained by Poling:

“Under EU law, the instruments made in these backstreets can be stamped with another country’s name so long as that country helps substantially transform the product. So, as the forged steel they’re working with here comes from Germany, the whole thing can be stamped ‘Made in Germany,’ and German instruments sell for much more than those stamped ‘Made in Pakistan.’”

Making matters worse, British suppliers rarely conduct quality inspections of their Pakistani manufacturers’ facilities. Part of the problem is the constant risk of terror attacks in Pakistan. It’s a dangerous area, and carrying out inspections in person is risky. Poling also found evidence suggesting the Pakistani surgical tool industry may be using child labor.

The MHRA declined meeting with Poling, but provided her with a statement saying they have “no evidence that non-compliant instruments are being supplied to the NHS.” Meanwhile, Brophy inspected the 19 instrument samples collected by Poling during her Pakistani trip, where she visited over 100 different instrument manufacturing facilities. Twelve of the 19 samples failed his inspection.

Poling even unearthed illegal activities during her investigation. While legal loopholes allow for a Pakistani manufacturer to label his goods as “Made in Germany” if the steel used is from Germany, it is illegal to use Pakistani or French steel, for example, and mark it as being German-made.

Undercover footage, in which she poses as a supplier of surgical instruments, shows two U.K. representatives of Regal Medical Instruments offering to sell her tools made with Pakistani steel stamped “Made in Germany,” so that she would then be able to resell them at an inflated price. According to the Pakistani representatives, they are already selling mid-priced French steel instruments to suppliers that bear the German mark, per the suppliers’ requests.

Non-Disposable Equipment Also Carries Contamination Risks

As discussed in my interview with Dr. David Lewis, Ph.D., a retired microbiologist with the Environmental Protection Agency (EPA) last year, non-disposable tools such as flexible sigmoidoscopes and colonoscopies are also risky for the patient. Since they must be reused, these tools require cleaning and sterilization before each use, both inside and out. However, testing reveals that this is virtually impossible, and the disinfection process used by most clinics and hospitals fails to properly clean and sterilize these tools.

As a result, patients take great chances when these tools are used on them, as they can spread all manner of infections from one patient to another. There is a solution: create flexible scopes that can be autoclaved (heat sterilized). But manufacturers have not been pressured to come up with such a design. As noted by Lewis, it really boils down to federal agencies failing to take the contamination issue seriously enough.

If you’re having a colonoscopy done, or any other procedure where a flexible endoscope will be used, be sure to ask how it is cleaned, and which cleaning agent is being used.

  • If the hospital or clinic uses peracetic acid, your likelihood of contracting an infection from a previous patient is very slim.
  • If the answer is glutaraldehyde, or the brand name Cidex (which is what 80 percent of clinics use), cancel your appointment and go elsewhere.

Asking what they use to clean the scope is a key question that could save your life. It’s important that we all start to do this because the FDA simply does not have the incentive to take action on it.

However, once enough people refuse to have these procedures done with glutaraldehyde-sterilized instruments, then clinics and hospitals will change, even if the FDA does nothing. It’s also crucial that health care professionals who are reading this start addressing the issue from the inside. You really need to be aware of this issue, and how it’s placing patients at risk.

As for flawed surgical tools, there’s very little you as a patient can do about it. Ideally, hospitals everywhere would hire someone to carefully inspect all surgical tools prior to use. In all, Poling’s report reveals there is much room for improvement in this industry, if we are to place patient welfare first.

In A True Christmas Miracle, Doctors Operate Successfully To Give Hands To A Man Born Without Them.


In what should be called a great success, surgeons in Poland on Thursday successfully attached a hand from a deceased donor to a man born without one. It was first such case in the world.

 “It is the first graft in the world of an upper limb onto an adult with this congenital defect,” said Adam Domanasiewicz, who headed the team of surgeons at Wroclaw Medical University Hospital was quoted by AFP.

“We are talking about a man who lived 32 years without this member.”

Polish

Up to now, a similar procedure had been performed only on newborn conjoined twins in Indonesia and Canada, Domanasiewicz said. Hands have also been grafted onto patients whose own limbs were amputated.

On December 15, the transplant was performed in an operation that lasted 13 hours. The patient, identified by his first name Piotr, was all smiles after the procedure and spoke of his dream for the future.

“I’d like to be able to hug my family using both hands. Until now I’d been using my stump,” he told private news channel TVN 24.

Though he’s only able to move his fingers, but doctors believe that he will gain more movement in his hand over time.

“This is an important breakthrough in neurophysiology and the practice of transplants because up to now it was thought that — in the case of this type of congenital defect — such grafts could not be done,” Domanasiewicz said.

The operation could open up new possibilities to hundreds of thousands of people in the world born without members whose only option to date has been prostheses, he added.

Up to now, a similar procedure had been performed only on newborn conjoined twins in Indonesia and Canada, Domanasiewicz said. Hands have also been grafted onto patients whose own limbs were amputated.

On December 15, the transplant was performed in an operation that lasted 13 hours. The patient, identified by his first name Piotr, was all smiles after the procedure and spoke of his dream for the future.

“I’d like to be able to hug my family using both hands. Until now I’d been using my stump,” he told private news channel TVN 24.

Though he’s only able to move his fingers, but doctors believe that he will gain more movement in his hand over time.

“This is an important breakthrough in neurophysiology and the practice of transplants because up to now it was thought that — in the case of this type of congenital defect — such grafts could not be done,” Domanasiewicz said.

The operation could open up new possibilities to hundreds of thousands of people in the world born without members whose only option to date has been prostheses, he added.

Second Degree Burns Treated with FISH SKIN in World First.


The benefits of cod liver oil have been well documented, but who knew fish skin had healing qualities? One woman discovered this the hard way, after suffering horrific burns to her arms, neck and face when a gas canister exploded at work. Fish skin was applied to waitress Maria Ines Candido da Silva’s second degree burns and made a huge difference to her recovery.

Doctors dressed her wounds with the skin of a Tilapia fish, a pioneering new therapy which has been proven to significantly reduce the trauma suffered by burn victims. The fish skin was chosen as it contains high levels of collagen type one and high degrees of humidity which help speed up healing and provide patients with essential proteins.

Maria, 36, from Russas, Brazil, said: “The explosion left me with horrific injuries. I was in absolute agony and desperate for anything to ease my suffering. “When doctors suggested putting fish skin on my wounds I found the idea really strange. But I jumped at the chance because they said it would be far less painful than the normal treatment and easier to manage.” “It was a really bizarre experience. I felt like I was in a sci-fi movie when the Tilapia fish skin was being put on. “At first the fish skin felt really cold but within minutes of it being laid on, I didn’t feel any more pain and it felt cool and comforting. I was really surprised and grateful that it didn’t smell either.”

In October, Maria was one of the first patients to be treated with the procedure as part of the pilot project at the IJF Burns Unit. Traditional treatment for burns in Brazil involves using sulphur sulphadiazine, a substance that heals wounds within 14 days, on average. Dressings and bandages must be changed daily to keep the wounds clean and the patient has to take an anaesthetic shower using anti-bacterial soap, otherwise the wound emits an offensive odour after 24 hours.

However, with this ground-breaking treatment, patients are pain free and the fish skin is reported to reduce healing by one or two days. Maria added: “Nurses used the creams when I first arrived. I was in excruciating pain already and the wounds on my hands were really deep. It was like I was being tortured and the touch of the water to shower it off caused so much pain.” The innovative biological dressing has been developed by a team of researchers over more than two years at the Nucleus of Research and Development of Medicines (NPDM) of the Federal University of Ceará (UFC). Plastic surgeon Dr Edmar Maciel is president of the Burns Support Institute, and one of the coordinators of the project. He said that fish skin triggers healing in roughly the same amount of time as topical creams, while causing patients less stress.

He added: “The benefits of this alternative technique include reducing the trauma and pain suffered by patients because their dressing does not have to be changed daily. With the traditional treatment, it does.”

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New Robot Can Operate on Eyes With More Accuracy Than a Human Surgeon


IN BRIEF
  • This two-armed, teleoperated robot can precisely move in a 10 mm space, giving it the ability to operate on eyes more accurately and with less potential for error than human surgeons.
  • Axsis is just one of a growing number of robot surgeons that are changing how doctors treat patients.

EASY ON THE EYES

Medical robots are increasingly being adopted in hospitals all around the world for a number of uses, including diagnostics, testing, and treatment. Due to their precision, they are proving particularly useful for surgery, and now another robot has been built to undertake a delicate operation: cataract surgery.

Cataract surgery is rather simple in concept, but incredibly delicate in reality. To do one, a surgeon must cut a small hole in the eye’s lens, remove the cloudy part that’s fogging up the patient’s vision, and replace it with a small piece of plastic similar to a permanent contact lens. The thin membranes of the eye are pretty sensitive, so the most likely complication from this surgery is that a surgeon pierces the back of the lens, causing hazy vision.

To counter this issue, Cambridge Consultants has created Axsis, a two-armed, teleoperated robot that can operate on eyes with more accuracy than a human surgeon. The robot has two pincers that can precisely move in a 10 millimeter (.4 inch) space, about the size of an eye lens. The surgeon controls the robot using two joysticks and an enlarged image on a screen. The size of the latter allows the surgeon to move the robot exactly where he wants it to go to perform the operation.

Axsis / Cambridge Consultants

ROBO SURGERY

Robots have been in the operating room for some time now and with increasing frequency. Popular surgical robot da Vinci was able to perform nearly half a million minimally intrusive operations in the US just last year, and other surgical robots have been used in operations to treat lung problems, appendix problems, and many others. In development are small microbots that operate inside the body to perform surgery, and still other robots are operating on eyes, just like Axsis.

While some aren’t sure what need Axsis has filled as lasers eliminate much of the risk involved with cataract surgery, the system could lead to other operations that require small, delicate movements. We’ll have to wait to see what Axsis gets its robot hands on in the future.