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Multicenter Cohort of 768 High-risk Patients With Symptomatic Gallstones, Adding Cholecystectomy Did Not Increase Length of Stay or Perioperative Morbidity, Supporting it as a Safe Single-stage Option

NCT07772440

CompletedN/A

Sponsor: Zagazig University

Conditions: Bariatric Surgery Candidate, Cholelithiases

Despite numerous single-center reports and meta-analyses, few studies have directly compared outcomes of LSG with versus without concomitant cholecystectomy exclusively in a high-risk cohort as defined above. To the best of our knowledge, only one prior study (Dincer and Dogan, 2019) specifically examined this high-risk population, and it included only 27 patients in the concomitant group. This multicenter retrospective comparative study - conducted in three research institutes in Egypt and Saudi Arabia - aims to evaluate the safety of concomitant cholecystectomy during LSG in high-risk patients with severe obesity and symptomatic cholelithiasis, using a control group of high-risk patients who underwent LSG alone. Our study provides the largest cohort to date specifically addressing this question in a high-risk population.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. High risk status (any of the following):

   * Multiple comorbidities: ≥ 3 obesity related comorbidities
   * Advanced age: ≥ 55 years
   * Increased anesthetic risk: ASA physical status class ≥ III
2. Symptomatic cholelithiasis

Exclusion Criteria:

1. Asymptomatic cholelithiasis
2. Prior cholecystectomy
3. Choledocholithiasis requiring preoperative ERCP
4. Suspected gallbladder malignancy
5. Emergency surgery for acute cholecystitis or pancreatitis
6. Concurrent other bariatric procedures (e.g., Roux en Y gastric bypass)