Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Hypothesis
The investigators hypothesize that the use of a larger calibration bougie (> 40-Fr) during laparoscopic sleeve gastrectomy will significantly reduce the incidence of postoperative gastric leak compared to standard smaller bougie sizes (36-Fr), without compromising weight loss outcomes or quality of life measures.
Hypotheses Tools
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 : LSG performed using a >40-Fr diameter calibration bougie | Active Comparator | LSG performed using a >40-Fr diameter calibration bougie |
|
| Group2 : Standard care using 36-Fr diameter calibration bougie | Active Comparator | Standard care using 36-Fr diameter calibration bougie |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bougie (>40-Fr) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.:
Leak Classification System:
| within 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment - Moorehead-Ardelt Quality of Life Questionnaire II (MA-II) | This validated instrument specifically designed for bariatric surgery patients evaluates six domains of quality of life:
Each domain is scored from -3 to +3 points, with total MA-II Score Range: -18 to +18 points. Score interpretation:
|
Not provided
Inclusion Criteria:
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:
Decision for bariatric surgery approved after multidisciplinary team discussion
Written informed consent obtained
Ability to complete questionnaires and attend follow-up visits
Stable weight (±5% for 3 months before surgery)
Normal preoperative upper gastrointestinal endoscopy or findings limited to:
Negative or minimal gastroesophageal reflux symptoms (GERD-Q score ≤8)
Exclusion Criteria:
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:
Severe gastroesophageal reflux disease is defined as:
Coagulation disorders or anticoagulation therapy that cannot be safely discontinued
Known silicon hypersensitivity or allergies to bougie materials
Active substance abuse or psychiatric conditions that may impair compliance
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Ashour, PhD | Contact | 00201002600970 | dr.mhany@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The surgical department of Medical Research Institute Hospital, Alexandria University | Recruiting | Alexandria | Alexandria Governorate | 21531 | Egypt |
FAIR data of this study can be requested. All will be saved in the Castor Electronic data capture system.
Whole study period
Ask contact person (Email the Principal investigator).
Not provided
Not provided
This is a prospective, randomized, double-blind controlled trial (RCT) comparing two different bougie diameters in laparoscopic sleeve gastrectomy. The study will involve:
Not provided
Not provided
Not provided
| Bougie (36-Fr) | Device |
|
|
| will be administered at baseline, 1 month, 6 months, and 1 year postoperatively |
| Food Tolerance Assessment - Suter Questionnaire | The questionnaire evaluates:
Total Suter Score Range: 0-27 points
| will be administered at 1, 3, 6, and 12 months postoperatively. |
| Weight Loss Assessment - Total Weight Loss Percentage (%TWL) | Calculation Formula: %TWL = [(Initial weight - Current weight) / Initial weight] × 100 (weight is measured in kilograms Kg) Success Criteria according to Eisenberg et al.:
| Baseline (preoperative) then 1, 3, 6, 12 months postoperative. |
| Postoperative Nausea and Vomiting Assessment | Assessment Tool: Modified Postoperative Nausea and Vomiting (PONV) Scale according to Apfel et al. Nausea Assessment (0-10 scale):
Vomiting Assessment:
Antiemetic Usage:
| Time Points: - 2 hours postoperatively - 6 hours postoperatively - 24 hours postoperatively - 48 hours postoperatively - Day 3 postoperatively |
| Pain Assessment - Visual Analog Scale (VAS) | VAS Pain Scale: 100mm horizontal line with anchors according to Hawker et al.
Pain Categories:
Additional Pain Assessments:
| 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 |
| Hospital Length of Stay Assessment | Measurement Parameters:
Discharge Criteria:
| Baseline till Day 3 postoperatively. |
| Postoperative Complications - Clavien-Dindo Classification | All complications within 30 days will be classified using the Clavien-Dindo system Grade I: Any deviation from normal postoperative course without need for pharmacological, surgical, endoscopic, or radiological interventions Grade II: Requiring pharmacological treatment with drugs other than allowed for Grade I complications Grade III: Requiring surgical, endoscopic, or radiological intervention
Grade IV: Life-threatening complications requiring intensive care management
Grade V: Death of patient Suffix "d": Added if patient suffers from complication at discharge (e.g., Grade IIId) | within 30 days |
| Comorbidity Resolution Assessment | The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies. Type 2 Diabetes Mellitus:
| Assessment Time Points: 6 months and 12 months postoperatively |
| Comorbidity Resolution Assessment | The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies. Arterial Hypertension:
| Assessment Time Points: 6 months and 12 months postoperatively |
| Comorbidity Resolution Assessment | The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies. Dyslipidemia:
| Assessment Time Points: 6 months and 12 months postoperatively |
| Comorbidity Resolution Assessment | The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies. Obstructive Sleep Apnea:
| Assessment Time Points: 6 months and 12 months postoperatively |
| Upper Gastrointestinal Evaluation | Mandatory 1-Year Upper GI Assessment:
| Mandatory 1-Year Upper GI Assessment GERD-Q Questionnaire Administration Timeline: - Preoperative: (baseline) - 1 month postoperative - 3 months postoperative - 6 months postoperative - 12 months postoperative |
| Nutritional and Laboratory Assessment | Baseline Assessment - Complete blood count (CBC) Normal ranges for a Complete Blood Count (CBC) vary by age, sex, and even the laboratory performing the test, but generally, adult normal ranges include:
| within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Comprehensive metabolic panel Normal ranges for a comprehensive metabolic panel (CMP) can vary by laboratory, but generally include values for glucose (70-100 mg/dL), calcium (8.5-10.2 mg/dL), blood urea nitrogen (BUN) (6-20 mg/dL), and creatinine (0.6-1.3 mg/dL). The CMP also includes liver function tests such as albumin (3.4-5.4 g/dL), total protein (6.0-8.3 g/dL), alkaline phosphatase (20-130 U/L), ALT (4-36 U/L), AST (8-33 U/L), and total bilirubin (0.1-1.2 mg/dL). (measured in Grams or milligrams per deciliter) | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Lipid profile Normal lipid profile levels in mg/dL for adults are generally Total Cholesterol below 200, LDL (bad) Cholesterol below 100, HDL (good) Cholesterol 40 or higher for men and 50 or higher for women, and Triglycerides below 150. | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Hemoglobin A1c A normal HbA1c range is generally considered below 5.7%, which indicates healthy blood sugar levels. The ranges for prediabetes and diabetes are 5.7% to 6.4% and 6.5% or higher, respectively. These results reflect average blood sugar levels over the past 2-3 months and are used to monitor, screen, and diagnose diabetes and prediabetes. | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Thyroid function tests (free T4) Normal thyroid function test values vary by lab, age, and pregnancy status, but a typical range for adults is 9.0-25.0 pmol/L for free T4. (measured in picomoles per liter) | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Thyroid function tests (Serum TSH) Normal thyroid function test values vary by lab, age, and pregnancy status, but a typical range for adults is 0.4-4.0 mIU/L for TSH. (measured in milli international unit per liter) | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Vitamin B12 Normal values for serum vitamin B12 typically fall in the range of 180-914 pg/mL. (measured in picograms per milliliter) | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Serum Folate Normal values for serum folate is around 4.0 ng/mL. (measured in nanograms per milliliter) | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - 25-hydroxyvitamin D Normal values for a 25-hydroxyvitamin D test vary, but generally, sufficiency is considered to be 20-50 ng/mL (50-125 nmol/L). Levels below 20 ng/mL (50 nmol/L) may indicate insufficiency, while levels below 10 ng/mL (25 nmol/L) often signify deficiency. | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Iron studies (ferritin, transferrin saturation, TIBC) Serum Iron: Measures the amount of iron in the blood. Males: 50-150 mcg/dL (8.95-26.85 micromol/L) Females: 35-145 mcg/dL (6.26-25.95 micromol/L) Total Iron-Binding Capacity (TIBC): Measures the blood's ability to attach to iron. General Range: 250-450 mcg/dL (45-81 micromol/L) Transferrin Saturation: The percentage of transferrin (a protein that carries iron) that is saturated with iron. Males: 20-50% Females: 15-45% Ferritin: Measures the body's iron stores. Men: 30-300 ng/mL Women: 20-200 ng/mL | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Albumin and prealbumin Normal adult albumin levels are typically 3.5 to 5.5 g/dL, while normal adult prealbumin levels are usually 15 to 36 mg/dL. | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Parathyroid hormone (PTH) Normal parathyroid hormone (PTH) levels typically fall between 10 and 65 pg/mL. | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Calcium and phosphorus Normal serum calcium levels for adults are roughly 8.6-10.3 mg/dL, while normal phosphorus levels are approximately 2.5-4.5 mg/dL. | within 1,6,12 months preoperatively. |
| Nutritional and Laboratory Assessment | Baseline Assessment: - Magnesium and zinc levels Normal magnesium levels are typically 1.7 to 2.2 mg/dL. Normal zinc levels, however, are more variable, with studies showing ranges such as 71.26-108.53 µg/dL in one population and 60.82-96.13 µg/dL in another. | within 1,6,12 months preoperatively. |