Robotic gastric Roux-en-Y bypass with or without concomitant cholecystectomy: pilot open label randomized trial

Debate continues about the need for prophylactic concomitant cholecystectomy (CC) at the time of Roux-en-Y gastric bypass (RYGB). The concerns over higher complication rates should be balanced against the risk of future biliary events. This pilot trial compared RYGB with CC to RYGB alone in patients without preoperative gallstones to inform a future large randomized trial.

Eligible patients without gallstones scheduled to undergo RYGB were randomized before surgery using a 1 : 1 allocation ratio. Surgeons and patients were not blinded. The primary outcome was a composite of intraoperative adverse events and 30-day postoperative complications. In addition, feasibility (time to enrolment, completion of follow-up) was added as a co-primary endpoint after the study started, driven by prolonged enrolment times and independent of trial results. Secondary outcomes included late complications, biliary events, length of operation, length of hospital stay, and quality of life.

In all, 96 patients were randomized between July 2018 and January 2023, and 95 were included in the full analysis due to one withdrawal. There were 49 and 46 patients in the RYGB with and without CC arms, respectively. The feasibility endpoint was met with regard to the completion of follow-up (95/95, 100% at 1 month; 88/95 93% at 18 months), but not the time to enrolment (21 patients randomized per year). The composite outcome of intraoperative and postoperative complications occurred in 44.9% and 26.1% of patients with and without CC, respectively (difference 18.8%; 95% confidence interval (c.i.) -0.6 to 36.8; P = 0.098). Patients with CC had a higher early comprehensive complication index score (mean 6.09 versus 2.06; difference 4.03; 95% c.i. 0.23 to 7.83; P = 0.047). Late (> 30 days) complications, length of hospital stay, and quality of life were similar between the two groups. During the 18-month follow-up, biliary events occurred in 3 patients without CC (6.5%), of whom 2 required biliary intervention (4.4%) compared with 1 patient with CC (2%), with no biliary interventions required.

The debate over performing CC during RYGB remains unresolved. The incidence of subsequent biliary interventions was low when CC was not performed. As a pilot study, this investigation sets the stage for a large randomized trial. Registration number: NCT04324515 (https://www.clinicaltrials.gov).