Bougie size and outcomes after laparoscopic sleeve gastrectomy
Impact of Bougie Diameter on Outcomes in Laparoscopic Sleeve Gastrectomy - A Randomized Controlled Trial
This test will see if using a larger (>40‑Fr) calibration bougie during sleeve gastrectomy lowers the chance of a postoperative stomach leak while keeping weight loss and quality of life similar for adults having the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | General Committee of Teaching Hospitals and Institutes, Egypt Government |
| Locations | 1 site (Alexandria, Alexandria Governorate) |
| Trial ID | NCT07230769 on ClinicalTrials.gov |
What this trial studies
This interventional comparison assigns patients undergoing primary laparoscopic sleeve gastrectomy to charting with either a >40‑Fr bougie or a standard 36‑Fr bougie and follows them through postoperative recovery. Key outcomes include postoperative gastric leak rates, total weight loss percentage (%TWL) at 6 months and 1 year, quality of life (MA‑II), food tolerance, nutritional status, and complications classified by Clavien‑Dindo. The protocol includes follow‑up visits at 1 month, 6 months, and 1 year to capture early and intermediate outcomes. The study is conducted at the Medical Research Institute Hospital, Alexandria University, with multidisciplinary surgical decision-making and written informed consent required.
Who should consider this trial
Good fit: Adults aged 18–70 who are approved for primary laparoscopic sleeve gastrectomy under 2022 ASMBS/IFSO BMI criteria (BMI ≥35, or BMI 30–34.9 with metabolic disease) and who provide informed consent are eligible.
Not a fit: Patients who are outside the age/BMI eligibility, undergoing revisional or non‑primary bariatric procedures, or unable to comply with follow‑up likely will not benefit from participation.
Why it matters
Potential benefit: If successful, using a larger bougie could lower the risk of postoperative gastric leaks and serious complications while preserving weight loss, quality of life, and better food tolerance.
How similar studies have performed: Prior observational and retrospective studies have reported mixed results—some suggest larger bougies may reduce leak risk while others show tradeoffs with weight loss—randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Alexandria, Alexandria Governorate
- The surgical department of Medical Research Institute Hospital, Alexandria University — Alexandria, Alexandria Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Ashour, PhD
- Email: dr.mhany@gmail.com
- Phone: 00201002600970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.