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 | Completed DMC

• 1 other identifier: ZU-IRP#2398/10-Jun-2026
• Study Type: observational
• Target: 2,512
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bariatric Surgery Candidate; Cholelithiases

Keywords

Laparoscopic sleeve gastrectomy; concomitant cholecystectomy; symptomatic cholelithiasis; high-risk obesity; comparative study; metabolic and bariatric surgery; Clavien-Dindo classification

Outcome Measures

Primary Outcomes (1)

• overall 30 day postoperative complication rate

  All patients followed an enhanced recovery after surgery (ERAS) protocol: early mobilization, multimodal analgesia, and gradual dietary progression. Discharge criteria included tolerance of oral intake, adequate pain control, and afebrile status. The primary outcome was overall 30 day postoperative. Data were extracted from electronic medical records, operative logs, and outpatient charts using a standardised form. Variables included demographics, BMI, comorbidities, ASA class, preoperative ultrasound findings, operative details, intraoperative events, and 30 day outcomes. Loss to follow up was defined as no documented contact or clinic visit within 30 days post discharge.

  30 day postoperative

Secondary Outcomes (3)

• Secondary Outcome Measures

  30 days postoperatively

• Length of hospital stay (LOS)

  30 DAYS POST OPERATIVE

• Clavien Dindo grade of complications

  30 days post operative

Study Arms (2)

A

LSG alone

B

LSG with concomitant cholecystectomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Data was collected from the archived medical records of the surgical departments of all the three research centers (in Zagazig city, Egypt, and the Najran University Hospital, Najran city, Saudi Arabia), and were retrospectively analyzed for all patients with inclusion criteria and the laparoscopic sleeve gastrectomy was done, with or without concomitant laparoscopic cholecystectomy during the period from January 2015 to January 2025 (the study period). Patients were divided into: * Group A (LSG alone): High-risk patients with symptomatic stones who underwent LSG without cholecystectomy. * Group B (LSG with concomitant cholecystectomy): High-risk patients with symptomatic stones who underwent LSG and simultaneous laparoscopic cholecystectomy. The decision to perform concomitant cholecystectomy was clinical, based on surgeon preference, patient consent, and intraoperative findings.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead
• Najran University: collaborator

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of general surgery

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: January 1, 2015
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share