Sleeve surgery showdown: does tube size matter for weight loss?
NCT ID NCT07230769
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The surgical department of Medical Research Institute Hospital, Alexandria University
RECRUITINGAlexandria, Alexandria Governorate, 21531, Egypt
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