Bougie size and outcomes after laparoscopic sleeve gastrectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.