Aims/hypothesis Mounting evidence indicates that Roux-en-Y gastric bypass (RYGB) ameliorates type 2 diabetes, but randomised trials comparing surgical vs nonsurgical care are needed. With a parallel-group randomised controlled trial (RCT), we compared RYGB vs an intensive lifestyle and medical intervention (ILMI) for type 2 diabetes, including among patients with a BMI <35 kg/m2. Methods By use of a shared decision-making recruitment strategy targeting the entire at-risk population within an integrated community healthcare system, we screened 1,808 adults meeting inclusion criteria (age 25–64, with type 2 diabetes and a BMI 30–45 kg/m2). Of these, 43 were allocated via concealed, computer-generated random assignment in a 1:1 ratio to RYGB or ILMI. The latter involved ≥45 min of aerobic exercise 5 days per week, a dietitian-directed weight- and glucose-lowering diet, and optimal diabetes medical treatment for 1 year. Although treatment allocation could not be blinded, outcomes were determined by a blinded adjudicator. The primary outcome was diabetes remission at 1 year (HbA1c <6.0% [<42.1 mmol/mol], off all diabetes medicines). Results Twenty-three volunteers were assigned to RYGB and 20 to ILMI. Of these, 11 withdrew before receiving any intervention. Hence 15 in the RYGB group and 17 in the IMLI group were analysed throughout 1 year. The groups were equivalent regarding all baseline characteristics, except that the RYGB cohort had a longer diabetes duration (11.4±4.8 vs 6.8±5.2 years, p=0.009). Weight loss at 1 year was 25.8±14.5% vs 6.4±5.8% after RYGB vs ILMI, respectively (p<0.001). The ILMI exercise programme yielded a 22±11% increase in V̇O2max (p <0.0001), whereas V̇O2max after RYGB was unchanged. Diabetes remission at 1 year was 60.0% with RYGB vs 5.9% with ILMI (p=0.002). The HbA1c decline over 1 year was only modestly more after RYGB than ILMI: from 7.7±1.0% (60.7 mmol/mol) to 6.4 ±1.6% (46.4 mmol/mol) vs 7.3±0.9% (56.3 mmol/mol) to 6.9±1.3% (51.9 mmol/mol), respectively (p=0.04); however, this drop occurred with significantly fewer or no diabetes medications after RYGB. No life-threatening complications occurred. Conclusions/interpretation Compared with the most rigorous ILMI yet tested against surgery in a randomised trial, RYGB yielded greater type 2 diabetes remission in mild-to-moderately obese patients recruited from a well-informed, population-based sample. Trial registration ClinicalTrials.gov NCT01295229

Background Randomized trials of bariatric surgery vs. lifestyle treatment likely enroll highly motivated subjects, which may limit the interpretation and generalizability of study findings. Objective To assess the feasibility of a population-based, Shared Decision Making (SDM) approach to recruitment for a trial comparing laparoscopic Roux-en-Y gastric bypass surgery to intensive lifestyle intervention among adults with mild-to-moderate obesity and type 2 diabetes. Setting A non-profit health system in King County, Washington that integrates care and coverage. Methods Adult members with a body mass index (BMI) between 30 and 45 kg/m2 taking diabetes medications were identified in electronic databases and underwent a multi-phase screening process. Candidates were given a telephone survey, education about treatment options for obesity and diabetes using decision aids, and an SDM phone call with a nurse practitioner in addition to standard office-based consent. Results We identified 1,808 members, and 828 (45.7%) had a BMI 30–34.9 kg/m2. Among these, 1,063 (59%) agreed to the telephone survey, 416 (23%) expressed interest in education about treatment options, and 277 (15%) completed the SDM process. The preferred treatment options were: 21 (8%) surgery; 149 (53.8%) diet and exercise; 5 (2%) pharmacotherapy; 8 (3%) none of the above; and 94 (34%) unsure. Ultimately, 43 participants were randomized to the trial. Significant differences were observed among people who did and did not agree to participate in our trial, mainly related to sex, disease severity, and hypoglycemic medication use. Conclusions This population-based, SDM-based recruitment strategy successfully identified, enrolled, and randomized subjects who had balanced views of surgery and lifestyle management. Even with this approach, selection biases may remain, highlighting the need for careful characterization of non-participants in all future studies.

Perineural cysts are an uncommon radiological finding and a rare cause of radicular leg pain. We report the clinical findings, imaging and operative appearances of a patient who presented with radicular leg and perineal pain, which was found to be associated with multiple sacral perineural cysts. The diagnostic and treatment options are explored. In particular, the use of percutaneous fine-needle cyst drainage as a guide to the value of surgery is discussed. Postoperative complications, such as pseudomeningocoele can occur, but may be effectively treated with lumbar drainage.

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An increase in infectious complications has been noted with the introduction of percutaneous femoral artery closure devices. We report five cases of infected groins and/or femoral arteries following angiographic procedures that were completed using the Perclose Suture Mediated Closure Device (Perclose). Each patient required drainage of the abscess and removal of the Perclose suture. Most patients required more extensive vascular reconstructive procedures. When these complications arise, we recommend expeditious drainage of the abscess, removal of the suture, and adequate exposure of the femoral artery to facilitate repair of the vessel.