For patients undergoing primary bariatric surgery, perioperative complications and safety were similar between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass (RYGB), the randomized BEST trial found.
Incidence of any adverse event (AE) at 30 days didn't significantly differ, occurring in 4.6% of sleeve gastrectomy and 6.3% of RYGB patients (OR 0.71, 95% CI 0.47-1.08, P=0.11), reported Suzanne Hedberg, MD, PhD, of the University of Gothenburg in Sweden, and colleagues.
The same went for serious AEs, which occurred in 1.7% and 2.7% of sleeve gastrectomy and RYGB patients, respectively (OR 0.63, 95% CI 0.33-1.22, P=0.19). No patients from either group died within 90 days of operations, they wrote in .
Small bowel obstruction emerged as the only serious AE difference between the two procedures. Among the 1,735 patients included in the study, no cases occurred among the sleeve gastrectomy group versus six (0.7%) in the RYGB group (P=0.01). This particular outcome may be attributed to the Lönroth surgical technique used in RYGB, the researchers said.
In addition, 30-day readmission rates didn't differ between the procedures (3.1% for sleeve gastrectomy and 4% for RYGB, P=0.33) and postoperative hospital stay was 1 day with either procedure. Average operating time was significantly shorter for sleeve gastrectomy compared with RYGB (47 vs 68 minutes), which isn't surprising due to the higher complexity of RYGB.
Overall, both procedures had low and very similar perioperative AE rates, Hedberg told 鶹ý. Because of this, the risk of AEs in the short-term doesn't need to be an important factor when choosing surgical procedure.
"There may be other risks and benefits in the long term to each patient, but the short-term surgical risk need not be the deciding factor," she said. "The long-term suitability of the procedure to each patient is of higher relevance in procedural choice, rather than short-term risk."
Calling this study a "nice start" and a "good foundation," Hedberg said her group is excited to track these patients for longer to measure the primary outcomes of the trial -- weight loss and serious AEs 5 years after surgery.
For the Bypass Equipoise Sleeve Trial () trial, 1,735 eligible patients were randomized to undergo one of the two bariatric procedures 24 hours prior to surgery. Patient weren't blinded to their procedure, and they were either informed prior to or after surgery which group they were in depending on their preference. All procedures were done laparoscopically and none were converted to open surgery. Virtually all patients also received antibiotic and thrombosis prophylaxis.
Recruited from 23 hospitals in Sweden and Norway, patients had to be at least age 18 and have a baseline BMI between 35-50. Though the upper BMI limit of 50 "covers most bariatric patients in Scandinavia," the researchers noted this may limit generalizability to other populations.
Some of the exclusion criteria included substance use disorder, uncontrolled psychiatric disease, inflammatory bowel disease, moderate-to-severe gastroesophageal reflux, hiatal hernia larger than 4 cm, and previous bariatric or other major upper gastrointestinal tract surgery. However, the main exclusion criteria was patient procedure preference. In recent years, the has climbed its way to being the most popular, though Hedberg's group pointed out that laparoscopic RYGB has been "the gold standard procedure for decades" in Scandinavia.
As expected with bariatric surgery, the study included mostly female patients (74%). Participants' average baseline BMI was 41 and weight was 118 kg (about 260 lb). Comorbidities included hypertension in 29%, sleep apnea in 14%, diabetes in 13%, dyslipidemia in 13%, and depression in 13%.
In both procedures, there were low rates of hiatal hernia (4.8% vs 5.6% for RYGB), intraoperative bleeding of over 100 mL (0.8% vs 0.8%), and splenic injury (0.1% vs 0%).
Disclosures
The work was supported by the Swedish Research Council, Region Västra Götaland, the Erling-Persson Foundation, the Healthcare Committee, and Agreement Concerning Research and Education of Doctors.
Hedberg disclosed no relationships with industry. Co-authors disclosed relationship with Baxter, Ethicon, Mölnlycke, Johnson & Johnson, the Swedish National Board of Health and Welfare, the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, and Novo Nordisk.
Primary Source
JAMA Network Open
Hedberg S, et al "Comparison of sleeve gastrectomy vs Roux-en-Y gastric bypass" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2023.53141.