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  • Pilot Open Randomized Controlled Trial Comparing Patients Undergoing Robotic Gastric Bypass With or Without Concomitant Cholecystectomy
  • https://doi.org/10.1093/bjs/znaf092.002Copy DOI Icon

Pilot Open Randomized Controlled Trial Comparing Patients Undergoing Robotic Gastric Bypass With or Without Concomitant Cholecystectomy

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Abstract

Abstract Background Patients experiencing rapid weight loss after bariatric surgery are at high risk of developing gallstones. However, the necessity of performing a concomitant cholecystectomy along with Roux-en-Y Gastric Bypass (RYGB) remains debated. Concerns over higher complication rates lead many surgeons to avoid performing concomitant cholecystectomy, particularly in patients without gallbladder pathology. Aims To compare outcomes between patients without cholelithiasis undergoing RYGB with and without concomitant cholecystectomy. Methods We conducted a pilot prospective open randomized study from 2018 to 2023 involving patients without gallstones who underwent RYGB either without concomitant cholecystectomy (control group) or with concomitant cholecystectomy (study group). Follow-up occurred during hospitalization and at 1, 3, 6, 12, and 18 months. The primary composite outcome was intraoperative adverse events (iAEs) and postoperative complications (Clavien-Dindo classification). Secondary endpoints included detailed iAEs and postoperative complications, biliary outcomes, operation duration, length of hospital stay, and quality of life (QoL). Results A total of 95 patients were included in the study. Demographics were similar between groups. There was no statistically significant difference in the composite outcome of intra- and postoperative complications between the control and study group (24.4% vs. 42%, p = 0.083). Detailed iAEs, postoperative complications according to Clavien-Dindo, length of hospital stay, operation duration, and QoL at 1 and 12 months were similar, while the study group showed a higher early comprehensive complication index (mean CCI of 2.10 vs. 6.09, p = 0.047). The incidence of biliary complications during follow-up was 6.8% in the control group and 2.0% in the study group, with 4.5% of patients receiving biliary interventions in the control group. Conclusion While overall intra- and postoperative complications did not significantly differ, patients experiencing concomitant cholecystectomy showed a higher early complication index. The incidence of subsequent biliary interventions was low in this patient cohort without preexisting cholelithiasis.

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