Bariatric Surgery With or Without Concomitant Laparoscopic Cholecystectomy in Morbidly Obese Patients With Gallbladder Stone Disease: A Prospective Randomized Controlled Pilot Study.

Abstract

Introduction: Imagine a surgeon's critical decision: Should the gallbladder be removed now, along with the planned bariatric surgery, or risk the complication and necessity of a second surgery later? This clinical dilemma is central to treating morbidly obese patients, who face a high prevalence of gallstone disease exacerbated by rapid postoperative weight loss. The best approach to managing existing gallstones in bariatric candidates remains debated, with debate focusing on whether combining laparoscopic cholecystectomy (LC) with bariatric surgery is both safe and advantageous. In this pilot study, we provide randomized evidence to guide this decision.

Methods: In this prospective randomized controlled pilot study, 58 morbidly obese patients with ultrasound-confirmed gallstones were randomly assigned to two groups: Group I (n = 30) received bariatric surgery and LC; Group II (n = 28) had bariatric surgery only, with LC delayed for symptoms. The primary outcomes were clearly defined as operative time, intraoperative complications, and postoperative morbidity, providing a focused measure of safety and efficacy. Secondary outcomes included hospital stay, pain, and follow-up gallstone symptoms.

Results: Baseline demographics and comorbidities were similar across groups. Operative time was longer in Group I (98.93 ± 11.58 min) than in Group II (75.18 ± 11.26 min, p < 0.001). An extra port was used in 20% of Group I patients, compared with none in Group II (p = 0.012). No significant differences were observed in bleeding, bile leakage, postoperative complications, or hospital stay. Group I reported higher pain scores (p < 0.001). During follow-up, 79.3% of Group II developed symptomatic gallstones, requiring later cholecystectomy.

Conclusion: Concomitant LC during bariatric surgery in morbidly obese patients with pre-existing gallstones is demonstrated to be safe and feasible, with acceptable increases in operative time and postoperative pain. The high rate (79.3%) of symptomatic gallstone development in patients who did not undergo concomitant cholecystectomy supports adopting routine concomitant LC to prevent future morbidity, thereby influencing clinical decision-making and standard practice. Trial Registration: ClinicalTrials.gov: NCT04567890.