Bougie Diameter on Outcomes in Laparoscopic Sleeve Gastrectomy

NCT07230769 | Recruiting

• 1 other identifier: Bougie Diameter Outcomes LSG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic sleeve gastrectomy (LSG) has become an increasingly popular bariatric procedure since its first performance by Hess and Hess in 1988 as a component of the biliopancreatic diversion-duodenal switch (BPD-DS) procedure, which was modified from Scopinaro's biliopancreatic diversion (BPD) and DeMeester's technique. In the early part of the twenty-first century, it was popularized as a first-step intervention before BPD or gastric bypass in the super obese and high-risk group of patients by Regan et al. Due to the unexpected good results in terms of weight loss and resolution of comorbidities, coupled with the simplicity of performing the procedure requiring intervention on only the stomach, sleeve gastrectomy gained status as a stand-alone bariatric procedure as demonstrated by Baltasar et al. The basic principle of LSG is to create a narrow stomach along the lesser curvature, depending on the left gastric artery, using a calibration bougie as a template to perform a vertical partial gastrectomy, resecting the greater curvature and fundus of the stomach according to the International Sleeve Gastrectomy Expert Panel Consensus Statement by Rosenthal et al. The procedure has demonstrated excellent outcomes in terms of weight loss and comorbidity resolution, making it one of the most commonly performed bariatric procedures worldwide according to the IFSO Worldwide Survey by Angrisani et al. Bougie Size Considerations and Rationale The selection of an appropriate bougie size during laparoscopic sleeve gastrectomy represents a critical technical decision that significantly influences both immediate surgical outcomes and long-term patient results. Calibration bougies serve as internal templates to standardize the gastric sleeve diameter and ensure consistent sleeve geometry across different surgeons and institutions, as described by Parikh et al. The diameter of the bougie directly determines the final gastric volume and the degree of restriction achieved, which in turn affects weight loss efficacy, food tolerance, and complication rates. Bougie sizes in current clinical practice typically range from 32-French (Fr) to 50-Fr, with most centers utilizing sizes between 34-Fr and 42-Fr according to the survey by Gagner et al. Small bougie sizes (32-36-Fr) create a more restrictive sleeve with potentially enhanced weight loss but may be associated with increased risks of stenosis, food intolerance, and gastroesophageal reflux disease as reported by Sakran et al. Medium bougie sizes (38-42-Fr) represent a compromise between restriction and safety, offering adequate weight loss while maintaining acceptable complication rates as demonstrated by Weiner et al. Large bougie sizes (44-50-Fr) provide greater sleeve capacity with improved food tolerance and potentially reduced leak rates, though concerns exist regarding long-term weight loss maintenance according to Abdallah et al. The rationale for comparing different bougie sizes stems from the ongoing debate regarding the optimal balance between surgical efficacy and safety. Recent meta-analyses have suggested that larger bougie sizes may be associated with reduced gastric leak rates without significantly compromising weight loss outcomes. However, the majority of existing evidence comes from retrospective observational studies with inherent limitations including selection bias, confounding variables, and lack of standardized outcome measures as noted by Shi et al. The current study aims to provide definitive prospective evidence comparing small (36-Fr) versus X large (larger than 40-Fr) bougie sizes in a randomized controlled trial design. Furthermore, the impact of bougie size on comorbidity resolution remains inadequately studied. Bariatric surgery has demonstrated remarkable efficacy in resolving obesity-related comorbidities, with diabetes remission rates ranging from 53% to 63% as reported by Schauer et al. and hypertension resolution rates varying from 8% to 50% depending on the specific criteria used according to Sjöström et al. The relationship between sleeve geometry, as determined by bougie size, and comorbidity resolution mechanisms requires further investigation to optimize patient outcomes and surgical technique selection.

Conditions

Bariatric Sleeve Gastrectomy

Keywords

Bougie Diameter; Outcomes in Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Gastric Leak Diagnosis and Classification

  The diagnosis of gastric leak must be fulfilled with any of the following criteria within 3 months postoperatively according to Benedix et al.: 1. Morphologic examination with contrast studies: * Abdominal CT scan with oral contrast showing extravasation * Upper gastrointestinal swallow studies demonstrating contrast leak * Abnormal perigastric pneumoperitoneum on imaging 2. Surgical evidence: * Direct visualization of staple-line disruption during exploratory re-intervention * Exit of methylene blue dye through drainage during postoperative course * Endoscopic visualization of staple-line defect 3. Endoscopic evidence: * Extravasation of contrast during endoscopy with C-arm fluoroscopy * Direct endoscopic visualization of gastric perforation or staple-line dehiscence Leak Classification System: * Type I (Early): 0-7 days postoperatively * Type II (Intermediate): 8-30 days postoperatively * Type III (Late): \>30 days postoperatively

  within 3 months postoperatively

Secondary Outcomes (26)

• Quality of Life Assessment - Moorehead-Ardelt Quality of Life Questionnaire II (MA-II)

  will be administered at baseline, 1 month, 6 months, and 1 year postoperatively

• Food Tolerance Assessment - Suter Questionnaire

  will be administered at 1, 3, 6, and 12 months postoperatively.

• Weight Loss Assessment - Total Weight Loss Percentage (%TWL)

  Baseline (preoperative) then 1, 3, 6, 12 months postoperative.

• Postoperative Nausea and Vomiting Assessment

  Time Points: - 2 hours postoperatively - 6 hours postoperatively - 24 hours postoperatively - 48 hours postoperatively - Day 3 postoperatively

• Pain Assessment - Visual Analog Scale (VAS)

  Assessment Schedule: - Immediate postoperative: Every 2 hours for first 24 hours - Postoperative day 1-2: Every 6 hours - Day 3 postoperatively: Final assessment - Follow-up visits: 1 week, 1 month

Study Arms (2)

Group1 : LSG performed using a >40-Fr diameter calibration bougie

ACTIVE COMPARATOR

LSG performed using a \>40-Fr diameter calibration bougie

Device: Bougie (>40-Fr)

Group2 : Standard care using 36-Fr diameter calibration bougie

ACTIVE COMPARATOR

Standard care using 36-Fr diameter calibration bougie

Device: Bougie (36-Fr)

Interventions

Bougie (>40-Fr) DEVICE

* Product: MID-TUBE orogastric calibration tube (Médical Innovation Development S.A.S, ref. MID131) * Classification: CE-marked class IIa medical single-use device * Length: 70 cm * Material: Medical silicon rubber, latex-free

Group1 : LSG performed using a >40-Fr diameter calibration bougie

Bougie (36-Fr) DEVICE

* Various manufacturers' single-use devices * All devices CE-marked and used per manufacturer instructions * Specific size selection based on center standard care protocols

Group2 : Standard care using 36-Fr diameter calibration bougie

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged between 18 and 70 years undergoing LSG as a primary bariatric procedure
• 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

You may not qualify if:

• History of previous gastric surgeries or bariatric procedures
• American Society of Anesthesiologists (ASA) score \>4
• Ongoing pregnancy or planned pregnancy within the study period
• 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
• 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
• Coagulation disorders or anticoagulation therapy that cannot be safely discontinued
• Known silicon hypersensitivity or allergies to bougie materials

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Alexandria Governorate, 21531, Egypt

RECRUITING

Central Study Contacts

Mohamed Ashour, PhD

CONTACT

00201002600970; dr.mhany@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery

Model Details: This is a prospective, randomized, double-blind controlled trial (RCT) comparing two different bougie diameters in laparoscopic sleeve gastrectomy. The study will involve: * Group1 : LSG performed using a \>40-Fr diameter calibration bougie * Group2 : Standard care using 36-Fr diameter calibration bougie

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: November 17, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Whole study period
• Access Criteria: Ask contact person (Email the Principal investigator).

Locations

EG (1)