Alcohol Abuse After Bariatric Surgery Common, Concerning


Individuals who undergo bariatric surgery, particularly Roux-en-Y gastric bypass (RYGP), have a significantly increased risk of developing a substance use disorder (SUD), in particular alcohol use disorder (AUD), new research shows.

The increased risk is not observed until after the first postoperative year, and risk factors include a preoperative history of substance use, especially alcohol; younger age; male sex; and smoking, said lead investigator Cameron Risma, MD, Pine Rest Christian Mental Health Services, Grand Rapids, Michigan.

In addition, people who chronically used opiates before the surgery tend to continue chronic use after surgery, Risma said.

Dr Cameron Risma

“We got the idea to study substance use disorders after bariatric surgery because we see a lot of it in our detox program at Pine Rest. It’s common. People come in years after surgery, and they never realized that this was an issue,” he told Medscape Medical News.

The findings were presented here at the American Academy of Addiction Psychiatry (AAAP) 29th Annual Meeting.

Fivefold Increased Risk

For the study, investigators conducted a PsychINFO and Web of Science search for articles published from 1996 to 2018 on the relationship between gastric bypass surgery and SUD.

They found that a 2013 prospective study that followed more than 4000 obese patients showed those who underwent bariatric surgery were nearly five times more likely to receive a diagnosis of alcohol abuse during a follow-up period of 8 to 22 years.

Another 2012 prospective study that followed almost 2500 bariatric surgery patients showed a significantly increased prevalence of symptoms of AUD during the second postoperative year compared to the first postoperative year (9.6% vs 7.3%).  There was no difference between the year immediately before (7.6%) or after (7.3%) the surgery.

The same study identified preoperative variables independently associated with increased risk of developing an AUD after bariatric surgery.  These included previous AUD, regular alcohol use (defined as >2 drinks per week), smoking, recreational drug use, male sex, RYGB, younger age, and low sense of belonging.

Two systematic reviews showed that approximately 8% of patients were chronic opiate users at the time of surgery, and that most continued using opioids in the year following surgery.

However, use of other substances after bariatric surgery remained unchanged.

Three hypotheses have been proposed to account for the link between bariatric surgery and addiction, Risma said.

“No one really knows exactly why, but one hypothesis is this idea of addiction transfer.  Binge eating can lead to obesity, so you get addicted to food. But after you have surgery, you can’t binge on food anymore so you turn to something else which happens to be a substance, to replace food. The idea is that you are using a substance to cope with a negative emotional state,” Risma said.

The next hypothesis is based on neurobiological mechanisms, supported by evidence from PET scans, which have shown similarly reduced D2 receptors in both pathologic obesity and addiction.

“It is possible that reduced striatal D2 receptors predispose an individual to search for strong dopaminergic reinforcement as a compensatory mechanism for dopamine hyposensitivity. This dopamine-based hypothesis is supported by neuroimaging studies showing that a rapid dopamine release is produced both by binge eating and IV alcohol infusion,” the authors write.

The third hypothesis is based on pharmacokinetic changes after RYGB, leading to a hypersensitivity to alcohol’s reinforcing effects.

“This is really interesting,” Risma said. “After Roux-en-Y gastric bypass, you get a hypersensitivity to alcohol’s effects, where even a small amount of alcohol can achieve very high blood alcohol concentrations.

“One drink can put you over the legal limit in less than 15 minutes, so it reaches a higher blood alcohol content and it takes longer for the alcohol to get out of your system. Some people report that even after a few sips they can feel a buzz. They go back to drinking the same amount, they get more drunk, and they can become addicted that way,” he said.

These changes are only observed in RYGB, and no other bariatric surgeries such as gastric banding or sleeve gastrectomy, Risma said.

“The results of our survey show that it’s primarily alcohol that becomes the substance of abuse,” he added. “But clinically, I’ll tell you, we see a lot of opiate use in our detox unit. This is something we would to like to investigate going forward, because we are seeing so much of it. People who have surgery have chronic pain, they can’t get off their opioids, and they come to us addicted and needing withdrawal and treatment afterwards.

“We would like to work with local bariatric surgical centers and ask how they are identifying people based on the risk factors we found in our survey, and then once they are identified, ask how they are treating them. Are you offering them classes, are you following up with them more often? We think that’s an area where we can make a clinical impact.”

A Growing Problem

Commenting on the findings for Medscape Medical News, Cornel N. Stanciu, MD, assistant professor of psychiatry, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, said the number of individuals undergoing bariatric weight loss procedures is expected to grow by 6% to 8% annually in the coming years.

“Positive outcomes can be quite striking. However, there are certain aspects which could worsen or emerge. With both obesity and addictions being stigmatized and overlooked as disorders of poor self-control, with perhaps common genetic, behavioral, social, neurobiological and pharmacokinetic factors, one emerging issue noted has been the association of bariatric surgery with development of postoperative addictions,” Stanciu said.

Dr Cornel Stanciu

As with other surgeries, the biggest focus has been on limiting opioid use to prevent addictive tendencies, but here the biggest association seems to be with the development of risky alcohol use, he added.

“Some studies report this rate to be as high as 21% when the procedure is done via the RYGB method, and 11% when banding is done,” Stanciu said.

The finding of a delay in developing alcohol abuse patterns a year after surgery has significant implications. Historically, the most rigorous follow-up and aftercare occur immediately after the procedure and tapers off throughout the coming years.

“In an era that is shifting towards the ambulatory setting, providing prolonged aftercare and monitoring may present challenges,” he added.

Identifying factors that predispose individuals to alcohol abuse after their bypass should prompt implementation of additional safety nets, Stanciu said.

“Here, they found [that patients with] a history of alcohol use, undergoing the RYGB type of procedure, young age, male gender, and smokers may be predisposed. It’s important to implement better screening focused on these risk factors, as well as a more robust pre- and post-surgical education and closer follow-up.

“Also, because alcohol problems may not appear for years after the procedure, it is critical for all clinicians involved in the care of bariatric surgery patients to proactively assess alcohol consumption and be able to intervene early,” he said.

However, he added, the frequency of RYGB is decreasing, he noted.

“Initially, RYGB was more popular than banding as it led to more drastic weight loss. However, newer approaches such as sleeve gastrectomy and endoscopic modalities are rapidly taking over. Whether these may have a greater association with alcohol and other addictive behaviors is a great unknown at this time,” Stanciu said.

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High Neoplasm Rate Seen After Conservative Treatment of Periappendicular Abscess


A trial comparing interval appendectomy to MRI follow-up after nonoperative treatment of periappendicular abscess was stopped prematurely after an interim analysis revealed a high neoplasm rate.

“The number of appendiceal tumors detected at interval appendectomy was alarming, and this is why the study was prematurely terminated due to ethical reasons,” Dr. Paulina Salminen of Turku University Hospital in Finland told Reuters Health.

“Periappendicular abscess is a form of complicated acute appendicitis that has already initially been treated conservatively, which is different from all other forms of complicated acute appendicitis (for example, perforated acute appendicitis),” she said by email. “The controversy with periappendicular abscess has been the need for interval – i.e., planned elective – appendectomy later on, after the initial successful conservative treatment.”

Dr. Salminen’s team had previously shown that antibiotic therapy can be effective as an initial treatment for acute uncomplicated appendicitis, with a five-year recurrence rate of 39%. (http://bit.ly/2IfaxmE).

For the current study, the team enrolled 60 patients (median age about 48; 60% men) who were diagnosed with periappendicular abscess in the emergency departments of five hospitals in Finland. Patients were randomized to either laparoscopic appendectomy or follow-up examinations with abdominal MRI. Both interventions were scheduled approximately three months after randomization.

As reported online November 28 in JAMA Surgery, a clinical suspicion of increased neoplasm risk among participants led to an unplanned interim analysis. The analysis revealed a 17% rate of neoplasms, with all cancers found in patients over age 40. The trial was terminated prematurely because of ethical concerns. Subsequently, two more neoplasms were diagnosed, resulting in an overall incidence of 20%.

At termination, the postoperative complication rate was 10% in the interval appendectomy group, and 33% of patients in the MRI follow-up group had undergone appendectomy at intervals ranging from 18 to 332 days.

Dr. Salminen said, “If this significant rate of neoplasms after periappendicular abscess is validated by future studies, it would argue (in favor of) routine interval appendectomy in this setting. We are planning on performing a prospective cohort study of periappendicular abscess patients in order to assess the associated neoplasm rate in a prospective national patient cohort.”

“What we can learn from (all) the data is that with acute uncomplicated appendicitis, laparoscopic appendectomy performed within 24 hours allows for same-day discharge of the patient and very few adverse events. This approach will also eliminate the doubt and risks associated with an incidental appendiceal tumor,” Dr. Kamal M.F. Itani of Boston University School of Medicine and the VA Boston Health Care System, told Reuters Health.

“This approach should be the gold standard against which any other intervention is measured for treatment failure, hospital length of stay, readmissions, complications, quality of life and costs,” he said by email.

By contrast, “for perforated appendicitis, after addressing the abscess, an interval appendectomy should be the standard of care,” Dr. Itani said. “A 20% rate of undetected tumor if appendectomy is not performed is unacceptable.”

“In the event a patient is treated with antibiotics for uncomplicated or complicated appendicitis as definitive early therapy either because of patient’s choice or severe comorbidities, I recommend an interval appendectomy or close follow up to rule out the possibility of an appendiceal tumor,” he concluded.

SOURCE:

JAMA Surgery 2018.

High Neoplasm Rate Seen After Conservative Treatment of Periappendicular Abscess


A trial comparing interval appendectomy to MRI follow-up after nonoperative treatment of periappendicular abscess was stopped prematurely after an interim analysis revealed a high neoplasm rate.

“The number of appendiceal tumors detected at interval appendectomy was alarming, and this is why the study was prematurely terminated due to ethical reasons,” Dr. Paulina Salminen of Turku University Hospital in Finland told Reuters Health.

“Periappendicular abscess is a form of complicated acute appendicitis that has already initially been treated conservatively, which is different from all other forms of complicated acute appendicitis (for example, perforated acute appendicitis),” she said by email. “The controversy with periappendicular abscess has been the need for interval – i.e., planned elective – appendectomy later on, after the initial successful conservative treatment.”

Dr. Salminen’s team had previously shown that antibiotic therapy can be effective as an initial treatment for acute uncomplicated appendicitis, with a five-year recurrence rate of 39%. (http://bit.ly/2IfaxmE).

For the current study, the team enrolled 60 patients (median age about 48; 60% men) who were diagnosed with periappendicular abscess in the emergency departments of five hospitals in Finland. Patients were randomized to either laparoscopic appendectomy or follow-up examinations with abdominal MRI. Both interventions were scheduled approximately three months after randomization.

As reported online November 28 in JAMA Surgery, a clinical suspicion of increased neoplasm risk among participants led to an unplanned interim analysis. The analysis revealed a 17% rate of neoplasms, with all cancers found in patients over age 40. The trial was terminated prematurely because of ethical concerns. Subsequently, two more neoplasms were diagnosed, resulting in an overall incidence of 20%.

At termination, the postoperative complication rate was 10% in the interval appendectomy group, and 33% of patients in the MRI follow-up group had undergone appendectomy at intervals ranging from 18 to 332 days.

Dr. Salminen said, “If this significant rate of neoplasms after periappendicular abscess is validated by future studies, it would argue (in favor of) routine interval appendectomy in this setting. We are planning on performing a prospective cohort study of periappendicular abscess patients in order to assess the associated neoplasm rate in a prospective national patient cohort.”

“What we can learn from (all) the data is that with acute uncomplicated appendicitis, laparoscopic appendectomy performed within 24 hours allows for same-day discharge of the patient and very few adverse events. This approach will also eliminate the doubt and risks associated with an incidental appendiceal tumor,” Dr. Kamal M.F. Itani of Boston University School of Medicine and the VA Boston Health Care System, told Reuters Health.

“This approach should be the gold standard against which any other intervention is measured for treatment failure, hospital length of stay, readmissions, complications, quality of life and costs,” he said by email.

By contrast, “for perforated appendicitis, after addressing the abscess, an interval appendectomy should be the standard of care,” Dr. Itani said. “A 20% rate of undetected tumor if appendectomy is not performed is unacceptable.”

“In the event a patient is treated with antibiotics for uncomplicated or complicated appendicitis as definitive early therapy either because of patient’s choice or severe comorbidities, I recommend an interval appendectomy or close follow up to rule out the possibility of an appendiceal tumor,” he concluded.

SOURCE:

JAMA Surgery 2018.

Bone loss, deterioration persist 5 years after gastric bypass


Adults with obesity who underwent Roux-en-Y gastric bypass experienced high-turnover bone loss and bone microarchitectural deterioration that persisted 5 years after the procedure, according to findings published in The Journal of Clinical Endocrinology & Metabolism.

“[Roux-en-Y gastric bypass]-associated skeletal fragility is mediated by accelerated, high-turnover bone loss and has been documented in the short term in multiple longitudinal studies,” Katherine G. Lindeman, of the endocrine unit at Massachusetts General Hospital, Boston, and colleagues wrote in the study background. “Collectively, these studies document that a decline in bone density up to 10% is common in the initial 1-2 years after [Roux-en-Y gastric bypass]. [Roux-en-Y gastric bypass] also leads to short-term declines in volumetric bone density of the axial and peripheral skeleton and weakening of peripheral bone microarchitecture. However, the long-term skeletal consequences of [Roux-en-Y gastric bypass] have not been well-characterized beyond these initial postsurgical years.”

In an observational study, researchers assessed longitudinal data on 21 patients with obesity undergoing Roux-en-Y gastric bypass at an academic medical center.

DXA was used to measure spine and hip areal bone mineral density, and quantitative CT was used to measure trabecular volumetric BMD of the spine. In a subset of participants, high-resolution peripheral quantitative CT was used to measure volumetric BMD and microarchitecture of the distal radius and tibia.

At each study visit, the researchers also measured serum type 1 collagen C-terminal telopeptide (CTX), which assesses bone resorption, and procollagen type 1 N-terminal propeptide (P1NP), which evaluates bone formation, and assessed physical activity. Study participants were advised to maintain a calcium intake between 1,200 mg and 1,500 mg daily and a vitamin D intake of 3,000 IU daily throughout the study.

At 5 years, researchers observed a mean 7.8% decrease in areal BMD at the spine and a mean 15.3% decrease in areal BMD at the total hip. However, the pace of spine areal BMD reduction slowed over time, with most of the bone loss observed within the first 2 years, according to researchers.

At the femoral neck, areal BMD decreased by a mean of 14.1% at 5 years. Additionally, researchers observed a mean 12.1% decrease in trabecular spine volumetric BMD at 5 years (P .001).

Peripheral sites showed continued and stable decreases over 5 years, with parallel reductions in cortical and trabecular microarchitecture. This led to a 20% decrease in estimated failure load at the radius and a 13% decrease at the tibia (P < .001), the researchers wrote.

After Roux-en-Y gastric bypass, significant increases in bone turnover markers were seen. At 2 years postoperatively, serum CTX was 196% higher vs. baseline levels and remained 150% above baseline at 5 years (P < .001). Increases were also seen in serum P1NP, reaching the highest point at 63% at 3.5 years after surgery, and remaining 34% higher at 5 years (P = .017 for comparisons vs. baseline).

“We found that areal and volumetric bone density and skeletal microarchitecture continue to deteriorate through 5 years after [Roux-en-Y gastric bypass] surgery, leading to substantial, cumulative bone loss,” the researchers wrote. “Adults undergoing [Roux-en-Y gastric bypass] warrant close follow-up to detect changes in bone density as well as to prevent secondary hyperparathyroidism and promote physical activity.” – by Jennifer Byrne

Corticosteroids therapy for sepsis: New Clinical guideline


https://speciality.medicaldialogues.in/corticosteroids-therapy-for-sepsis-new-clinical-guideline/

Doctors Replaced a Soldier’s Lost Ear Using a Wild Medical Technique


Army Pvt. Shamika Burrage almost died in 2016. The 19-year-old was returning back to base after visiting her family when her tire blew out, causing her to lose control of the car, which flipped and skidded for 700 feet before ejecting her. Thanks to prompt medical care, she only lost an ear instead of her life. But now, thanks to military plastic surgeons, she’s even got that back.

In a first for United States Army doctors, Burrage received an ear transplant that was grown from her own tissue inside her own body. A team, led by Lieutenant Colonel Owen Johnson III, the chief of plastic and reconstructive surgery at William Beaumont Army Medical Center in El Paso, Texas, harvested cartilage from Burrage’s ribs, carved it into the shape of an ear, and implanted it under the skin in her arm. There, it developed blood vessels, which Johnson says will allow Burrage to regain feeling in the ear once it’s healed. In an announcement released on Monday, Johnson called the operation a success.

ear growing under forearm skin
Army doctors grew a new ear for a soldier who lost one in a car crash.

“The whole goal is by the time she’s done with all this, it looks good, it’s sensate, and in five years if somebody doesn’t know her they won’t notice,” said Johnson in the statement. “As a young active-duty Soldier, they deserve the best reconstruction they can get.” Johnson also used skin from Burrage’s arm to help conceal the borders of the transplant and make the reconstruction more seamless. Soon Burrage, who is now 21 years old, will bear few marks of her fateful crash.

This procedure may be the U.S. Army’s first such transplant, but it’s definitely not the first time doctors have grown ears for patients. In 2012, doctors at Johns Hopkins University grew an ear under the forearm skin of a cancer survivor. In January, doctors in China successfully grew and transplanted ears onto children born with a birth defect that affects natural ear growth. In 2015, a child who had suffered burn injuries received the first 3D-printed nose.

Recent history suggests that procedures like Burrage’s will likely become more and more commonplace. Some doctors have even predicted that 2019 will be the year we’ll regularly print new noses and ears with human cells. In the meantime, Burrage has a couple more surgeries before her procedure can be considered complete. She’s feeling good about the surgery, though.

The ear had closed up because of the trauma from the accident, but Burrage says she can hear just as well as she could before. “I didn’t lose any hearing and [Johnson] opened the canal back up.”

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FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults


The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.

Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, a majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”

According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of nearly 50,000 people. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs or concussions. A majority of patients with concussion symptoms have a negative CT scan. Potential effects of TBI can include impaired thinking or memory, movement, sensation or emotional functioning.

“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.”

The Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.

The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions on a CT scan 99.6 percent of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.

The Brain Trauma Indicator was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Novel device that quickly identifies severity of concussions


https://speciality.medicaldialogues.in/novel-device-that-quickly-identifies-severity-of-concussions/

Trial Confirms Lap Colectomy Extraction Location Affects Hernia Risk


A randomized controlled trial has shown that patients are less likely to develop an incisional hernia in the 2.5 years after a laparoscopic colectomy when they have a transverse instead of a midline specimen extraction site.

The findings confirm results from smaller retrospective studies, but offer the strongest evidence demonstrating that extraction site location significantly affects incisional hernia risk.

The study also highlights the need for careful selection of patients who undergo transverse incisions.

In an intent-to-treat analysis, investigators found no significant difference in incisional hernias between midline and transverse incisions one year after surgery. This may be explained by the high number of patients randomly assigned to a transverse incision who were switched to a midline, open or Pfannenstiel incision, indicating the transverse incision is best reserved for selected patients.

“These results suggest that while a transverse incision results in less internal hernias compared to midline, it is less versatile and may only be feasible in select patients,” wrote Lawrence Lee, MD, PhD, and his colleagues from the Steinberg-Bernstein Centre for Minimally Invasive Surgery and Innovation, McGill University Health Centre, in Montreal.

The study is published online in the Annals of Surgery (2017 Nov 21. [Epub ahead of print]).

Dr. Lee and his colleagues randomly assigned 165 adult patients to a transverse (n=79) or midline (n=86) specimen extraction site, of which 141 completed one-year follow-up. Eligible patients underwent an elective laparoscopic right hemicolectomy, left hemicolectomy or rectosigmoid resection for malignant or benign disease, and did not have inflammatory bowel disease, emergency surgery, mid to low-rectal resection, transverse colectomy, single-incision laparoscopic surgery, planned stoma, ASA class IV to V status or morbid obesity. They could not participate in another trial that would have influenced the results.

Twenty-three of the 79 patients allocated to transverse were converted to open (n=15), or received a midline (n=10) or Pfannenstiel (n=8) incision.

With one year of follow-up after surgery, 141 patients were included in the intent-to-treat analysis, including 68 in the transverse group and 73 in the midline group. The incidence of incisional hernias was similar between the transverse group at 2% and the midline group at 8% (P=0.065). With a mean follow-up of 29.9 months in the transverse group and 30.6 months in the midline group, the incidence of incisional hernias was 14% in the midline group and 6% in the transverse group. Of the four patients who developed incisional hernias in the transverse group, only one underwent a transverse incision and three were converted to midline laparotomy during the initial surgery.

The per-protocol analysis at one year included 117 patients—52 in the transverse group and 65 in the midline group—with incisional hernia rates of 2% and 9%, respectively. Mean follow-up time in the per-protocol analysis was 29.1 months in the transverse group and 29.9 months in the midline group. At that time, incisional hernia incidence was 2% after transverse and 15% after midline incisions (P=0.013).

Conor P. Delaney, MD, professor of surgery and chair of the Digestive Disease and Surgery Institute of the Cleveland Clinic, in Ohio, said the study brings a new level of evidence to an idea that surgeons believe intuitively.

In 2013, he and his colleagues published a retrospective review of 280 laparoscopic colorectal procedures over a six-year period (Am J Surg 2013;205:264-267). They reported that midline hernia rates, although lower than with traditional open surgery, were higher than non-midline rates.

Non-midline incisions are a “very simple way to help patients’ long-term outcomes become improved,” he said, adding that non-midline incisions also tend to cause less pain.

“This study is a really good reminder of the high level of evidence that, wherever possible, we’ve got to get incisions away from the midline.”

The investigators said the number of incisional hernias throughout the study period was lower than in previous studies, and may reflect the low rates of surgical site infections (SSIs), a known risk factor for the development of incisional hernias. During the five years when patients were being enrolled in this study, SSIs were the target for multiple quality improvement initiatives at the study institution.

The investigators noted that they did not use the small bites technique, which has been shown to result in fewer incisional hernias after primary midline fascial closure. “It is unknown whether application of the small bites technique would have altered the result,” they wrote.

Patients in the transverse group reported higher scores in body pain (denoting less pain) and social function domains on the Medical Outcomes Study 36-Item Short Form Health Survey. Patients with midline incisions reported better cosmesis scores, although body image scores did not differ.

“There is a trade-off between cosmesis and risk of incisional hernia that should be important elements of the informed consent process for patients undergoing laparoscopic colectomy,” they wrote.

In the midline group, the umbilical port site was sharply extended using electrosurgery through the linea alba to create a periumbilical midline extraction incision. In the transverse group, an incision was created lateral to the linea semilunaris and rectus sheath. The external oblique aponeurosis was divided parallel to its fibers, and the internal oblique and transversus abdominis split in the direction of their fibers.

An independent surgeon who was not involved in the clinical care of the patient performed the hernia assessment by physical examination, as neither patient nor health care providers could be blinded to group assignment.

Reduced rates of incisional hernia was a hoped-for benefit of the smaller incisions enabled by laparoscopic surgery. However, laparoscopic versus open colectomy randomized trials have not demonstrated a difference in the incidence of incisional hernias with long-term follow-up.

A Cochrane Review of randomized trials comparing midline with transverse incisions concluded that transverse incisions were less painful, had less effect on pulmonary function, and were associated with a decreased incidence of incisional hernia compared with midline incisions, but these data involved open surgery only (Cochrane Database Syst Rev 2005;[4]:CD005199).

Antibiotic-Only Approach to Appendicitis Risky for Certain Patients


Elderly, Medically Complex Patients Have Lower Risk For Death With Surgery

 

Currently in the United States, about twice as many adults with appendicitis are treated without an operation as 20 years ago, but nonoperative management of an infected appendix is linked to a higher death rate in the hospital, according to the first large U.S. study to look at long-term trends in appendicitis.

Studies in Europe over the past two decades have shown that some patients with uncomplicated appendicitis can be treated successfully with antibiotics alone. These results appear to be driving the change in surgical practice for appendicitis in the United States.

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But this new study raises questions about whether a nonoperative approach is a safe option for older or medically complex patients.

After matching the cases in both treatment groups on age, sex and comorbidity index, the investigators reported a nearly sixfold increased death rate in the nonoperative care group. Compared with 0.08% of surgically treated patients with appendicitis, 0.47% of the nonoperatively managed patients died in the hospital.

“I am concerned that surgeons may be overextrapolating the European data and applying nonoperative management of appendicitis to patients for whom it is inappropriate,” said the study’s principal investigator Isaiah R. Turnbull, MD, PhD, assistant professor of acute and critical care surgery, Washington University School of Medicine, in St. Louis. “We as a community of surgeons need to consider whether nonoperative management of uncomplicated appendicitis, such as an antibiotics-first approach, is appropriate for these high-risk patients.”

Dr. Turnbull presented the findings at the 2017 Clinical Congress of the American College of Surgeons. The study was published last month in the Journal of Surgical Research (pii: S0022-4804[17]30661-3).

  • Researchers analyzed 477,680 adults with a primary diagnosis of appendicitis between 1998 and 2014.
  • According to their findings, the proportion of patients treated with early operations decreased from 94.6% to 92.1%, while nonoperative management increased from 2.3% to 4.9%.
  • Researchers also observed a sixfold increase in mortality for nonoperative patients.
  • There are approximately 250,000 cases of appendicitis in the U.S. annually.

The researchers analyzed the type of treatment for 477,680 adults with a primary diagnosis of appendicitis between 1998 and 2014 included in the National Inpatient Sample, a database of hospitalized patients representing more than 96% of the U.S. population.

Although the database did not specify whether the appendix had ruptured, investigators excluded patients who had a peritoneal abscess, as well as patients younger than 18 years of age and those who had elective admission.

Over the study period, the proportion of patients treated with an early operation decreased from 94.6% to 92.1%. Use of nonoperative management increased twofold, from 2.3% of patients with appendicitis in 1998 to 4.9% in 2014. Most of the remaining patients had an operation later than the second day in the hospital.

Additionally, in 135,856 patients with appendicitis from 2010 to 2014, the investigators compared patient characteristics and outcomes. A total of 131,162 patients underwent an early operation, primarily an appendectomy on the day of hospital admission or the next day. Another 4,694 patients received nonoperative management, defined as no operation or placement of an abdominal drain. It is not clear from this data set whether these patients received antibiotic therapy.

In this subgroup of patients from the most recent five-year period, those receiving nonoperative management were, on average, eight years older than patients in the early operation group—49 versus 41 years. They also had a significantly higher comorbidity index, with a score of 1.35 compared with 0.78.

The odds of dying of any cause during the hospitalization was 2.4 times higher in patients who had no operation compared with those who underwent an early operation.

“Our findings suggest that U.S. surgeons are selecting elderly, sicker patients for nonoperative management, possibly because they believe these patients are not good candidates for an operation,” Dr. Turnbull said. “However, these patients are at increased risk of a poor outcome if nonoperative management fails because they lack the physiologic reserve or ability to tolerate illness.” Many of the European studies of antibiotic treatment for appendicitis excluded elderly patients and had a patient age that was much younger than in this U.S. database, he said.

This is the first known study to show an association between nonoperative management of appendicitis and death. Mortality is rare in appendicitis, so tracking it requires a large data set.

Dr. Turnbull said he was cautious about making clinical recommendations based on this study alone, saying the primary conclusion from these data is that more information is needed. “That said, for me, I would counsel my colleagues that these data suggest that nonoperative management may not be appropriate for elderly patients or patients with significant medical comorbidities.”

The ongoing CODA trial is expected to provide some answers on how to best treat elderly patients as it is open to adults of all ages. It explicitly excludes several populations of medically complicated patients, such as those who have liver failure, immunologic deficiency, or second infectious conditions such as pneumonia.

Lead investigators in the CODA trial said the study presented at the ACS is interesting, but caution should be applied when interpreting the results. Giana H. Davidson, MD, MPH, assistant professor at the University of Washington, said early results from CODA show that surgeons have significant bias in giving treatment recommendations and patients have preferences that drive treatment decisions, which will not be accounted for using administrative data. “These preferences may also be associated with worse outcomes.”

David R. Flum, MD, MPH, professor of surgery and director of the Surgical Outcomes Research Center at the University of Washington, in Seattle, said the CODA trial was developed to answer some of the questions raised by the new study. “There are real questions about actual rates of adverse outcomes with antibiotic management of appendicitis.” Dr. Flum is a member of the editorial board of General Surgery News.

“While it’s likely that claims-based studies like this may show higher rates of adverse events because of confounding, the finding of increased risk is worrisome. For antibiotics to be offered as an alternative to appendectomy in the United States, we need a rigorous [randomized controlled trial] to establish the comparative rate of adverse events. For this reason, we think antibiotics should remain in the research space until CODA is completed and the results are released in 2020.”

Both Dr. Davidson and Dr. Flum commented based on the study abstract.

Appendicitis is the most common intraabdominal surgical emergency in the United States, with more than 250,000 cases annually.

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