Seven-Year Results of a Randomized Trial Comparing Banded Roux-en-Y Gastric Bypass to Sleeve Gastrectomy for Type 2 Diabetes and Weight Loss.

INTRODUCTION: Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are common bariatric procedures that are effective in treating type 2 diabetes (T2D) in patients with obesity. Limited data from randomized trials are available comparing longevity of diabetes remission directly between the two procedures beyond 5 years. METHODS: A prospective, randomized, parallel, two-arm, clinical trial comparing the outcomes of silastic ring (SR)-LRYGB versus LSG was conducted at a single (Auckland, New Zealand) center. Patients and researchers were blinded until the 5-year mark and follow-up after this was unblinded. Eligible patients had T2D of > 6 months duration with a BMI 35--65 kg/m2 and were aged 20-55 years. Randomization was 1:1 to SR-LRYGB and LSG following induction of anesthesia and was stratified by age group, BMI group, ethnicity, diabetes duration, and insulin therapy. The primary outcome was T2D remission, defined as HbA1c < 6% (42 mmol/mol), without the use of glucose-lowering medications. RESULTS: A total of 114 patients were randomized of whom 6 died before the 7-year follow-up (2 SR-LRYGB, 4 LSG). Diabetes remission, assessed in 89 (82.4%) of the remaining patients, was seen in 23/50 (46.0%) after SR-LRYGB and 12/39 (30.8%) after LSG (adjusted OR 4.64, 95% CI 1.39, 15.52, p = 0.013). Percentage total body weight loss was greater after SR-LRYGB than LSG (26.2% vs 13.4%; absolute difference 12.8%; 95% CI 7.2%, 18.2%; p < 0.001). Complication rates were similar between groups. CONCLUSION: SR-LRYGB was superior to LSG for diabetes remission and weight loss at 7 years following surgery, with acceptable complication rates.

Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial.

BACKGROUND & AIMS: Antibiotic treatment is the standard care for patients with uncomplicated acute diverticulitis. However, this practice is based on low-level evidence and has been challenged by findings from 2 randomized trials, which did not include a placebo group. We investigated the non-inferiority of placebo vs antibiotic treatment for the management of uncomplicated acute diverticulitis. METHODS: In the selective treatment with antibiotics for non-complicated diverticulitis study, 180 patients hospitalized for uncomplicated acute diverticulitis (determined by computed tomography, Hinchey 1a grade) from New Zealand and Australia were randomly assigned to groups given antibiotics (n = 85) or placebo (n = 95) for 7 days. We collected demographic, clinical, and laboratory data and answers to questionnaires completed every 12 hrs for the first 48 hrs and then daily until hospital discharge. The primary endpoint was length of hospital stay; secondary endpoints included occurrence of adverse events, readmission to the hospital, procedural intervention, change in serum markers of inflammation, and patient-reported pain scores at 12 and 24 hrs. RESULTS: There was no significant difference in median time of hospital stay between the antibiotic group (40.0 hrs; 95% CI, 24.4-57.6 hrs) and the placebo group (45.8 hrs; 95% CI, 26.5-60.2 hrs) (P = .2). There were no significant differences between groups in adverse events (12% for both groups; P = 1.0), readmission to the hospital within 1 week (1% for the placebo group vs 6% for the antibiotic group; P = .1), and readmission to the hospital within 30 days (11% for the placebo group vs 6% for the antibiotic group; P = .3). CONCLUSIONS: Foregoing antibiotic treatment did not prolong length of hospital admission. This result provides strong evidence for omission of antibiotics for selected patients with uncomplicated acute diverticulitis. ACTRN: 12615000249550.

Prophylactic Foley catheter insertion into defunctioning ileostomy to reduce obstruction after colorectal surgery: pilot randomized controlled trial.

BACKGROUND: Defunctioning ileostomies provide faecal diversion in major colorectal surgery. This reduces the consequences of an anastomotic leak. However, the formation of an ileostomy carries risks including obstruction at the level of the fascia. Post-operative oedema at the level of the fascia may contribute to obstruction. We hypothesize that the prophylactic insertion of a Foley catheter into the afferent limb of a defunctioning loop ileostomy may help decompress and improve time to low-residue diet (LRD). The objective of the study was to assess the feasibility of a Foley catheter, prophylactically inserted into the afferent limb of a defunctioning loop ileostomy, after major colorectal surgery. METHODS: The study was a prospective pilot-randomized controlled trial. Ethical approval was obtained from Northern B Health and Disability Ethics Committee 15/NTB/91 ANZCTR Trial ID: ACTRN12615000691549. RESULTS: Forty-nine patients undergoing major elective colorectal surgery with a defunctioning ileostomy, between the years of 2015 and 2018 at North Shore Hospital, Auckland, New Zealand were included in this study. Patients were randomly allocated to either the Foley catheter (n = 26) or non-Foley catheter (n = 23) group. The median time taken to tolerate LRD the primary outcome, was 2 days in the Foley group versus 2 days in the non-Foley group (P = 0.05). There were no differences in the secondary outcome measures such as time to stoma output, length of stay or complications. CONCLUSION: This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group. There was no difference in length of stay, time to flatus or stoma output.