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Sleeve surgery showdown: does tube size matter for weight loss?

NCT ID NCT07230769

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the size of the tube (bougie) used during laparoscopic sleeve gastrectomy affects outcomes like weight loss and complications. About 100 adults with obesity will be randomly assigned to receive a small (36-Fr) or extra-large (over 40-Fr) bougie. The goal is to find the best size to maximize weight loss while minimizing risks like stomach leaks.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Ages

18 to 70 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. Adult patients aged between 18 and 70 years undergoing LSG as a primary bariatric procedure 2. Body mass index (BMI) criteria according to 2022 ASMBS/IFSO guidelines: * BMI ≥35 kg/m² regardless of presence, absence, or severity of comorbidities, OR * BMI 30-34.9 kg/m² (Class I obesity) with metabolic disease and inadequate response to nonsurgical methods, including: * Type 2 diabetes mellitus * Arterial hypertension * Dyslipidemia * Obstructive sleep apnea syndrome and other severe respiratory disorders * Cardiovascular disease (coronary artery disease, heart failure, atrial fibrillation) * Asthma * Fatty liver disease and nonalcoholic steatohepatitis * Chronic kidney disease * Polycystic ovarian syndrome * Infertility * Pseudotumor cerebri * Bone and joint diseases 3. Decision for bariatric surgery approved after multidisciplinary team discussion 4. Written informed consent obtained 5. Ability to complete questionnaires and attend follow-up visits 6. Stable weight (±5% for 3 months before surgery) 7. Normal preoperative upper gastrointestinal endoscopy or findings limited to: * Los Angeles (LA) Classification Grade A reflux esophagitis (minimal mucosal breaks \<5mm) * Mild gastritis without active ulceration 8. Negative or minimal gastroesophageal reflux symptoms (GERD-Q score ≤8) Exclusion Criteria: 1. History of previous gastric surgeries or bariatric procedures 2. American Society of Anesthesiologists (ASA) score \>4 3. Ongoing pregnancy or planned pregnancy within the study period 4. Significant esophageal and gastric pathology, including: * Los Angeles (LA) Classification Grade B, C, or D reflux esophagitis * Hiatal hernia or any paraesophageal hernia * Barrett's esophagus of any length * Active peptic ulcer disease * Gastric polyps \>1cm or suspicious lesions 5. Severe gastroesophageal reflux disease is defined as: * GERD-Q score \>8 * Daily proton pump inhibitor (PPI) dependency with breakthrough symptoms * Endoscopic evidence of LA Grade B, C, or D esophagitis 6. Coagulation disorders or anticoagulation therapy that cannot be safely discontinued 7. Known silicon hypersensitivity or allergies to bougie materials 8. Active substance abuse or psychiatric conditions that may impair compliance

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • The surgical department of Medical Research Institute Hospital, Alexandria University

    RECRUITING

    Alexandria, Alexandria Governorate, 21531, Egypt

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