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NCT07772440Completed

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

High-Risk Patients With Morbid Obesity and Symptomatic Cholelithiasis: Safety of Concomitant Cholecystectomy During Laparoscopic Sleeve Gastrectomy - A Multicenter Retrospective Comparative Study

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
2512 (actual)
First submitted
11 Aug 2026
Start date
1 Jan 2015
Primary completion date
1 Jan 2025
Lead sponsor
Zagazig University
Diseases
Obesity
NCT number
NCT07772440

What you commit to

  • Study type: Observational
  • Participants enrolled: 2512
  • From 1 Jan 2015 to the primary completion date, 1 Jan 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior cholecystectomy
  • Emergency surgery for acute cholecystitis or pancreatitis
  • Concurrent other bariatric procedures (e.g., Roux en Y gastric bypass)

Other illness

  • Suspected gallbladder malignancy

Other

  • Asymptomatic cholelithiasis
  • Choledocholithiasis requiring preoperative ERCP

Who the study is looking for

  • 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
  • Symptomatic cholelithiasis

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.