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One surgery or two? study tests combining gallbladder removal with Weight-Loss surgery

NCT ID NCT07772440

Disease control Sponsor: Zagazig University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study looks at whether it is safe to remove the gallbladder at the same time as laparoscopic sleeve gastrectomy (a common weight-loss surgery) in patients who are at high risk due to age, multiple health problems, or increased anesthesia risk. It compares patients who had both procedures with similar patients who had only the weight-loss surgery, tracking complications within 30 days. The findings could help surgeons decide whether combining the procedures is a good option for this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Concomitant cholecystectomy (gallbladder removal) during laparoscopic sleeve gastrectomy
What this could lead to
If safe, this could support doing gallbladder removal at the same time as weight-loss surgery for high-risk patients, avoiding a second operation.
What could go wrong
This is a retrospective review, not a randomized trial, so results may be influenced by selection bias. Combining surgeries may increase operative time and complication risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,512 people

The number who actually took part.

Started

Jan 2015

Finished

Jan 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cholelithiasis morbid obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bariatric surgery candidate Cholelithiases

More trials for these conditions

Other studies related to the condition(s) this trial covers.