Does Antrum Size Matter in Sleeve Gastrectomy?

Study Overview
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Brief Summary
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Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control and intestinal functions. LSG is easier regarding its technical aspects and does not need any intestinal anastomosis, begin limited to the stomach. The most frequent and sometimes dangerous complications are leaking, haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. Despite its established efficacy and safety, controversy still exists on optimal operative technique for LSG: bougie size, the distance of resection margin from the pylorus, the shape of the section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing is among the most controversial issues 11[6]. In literature, different authors have adopted a resection distance from the pylorus between 2 and 6-7 cm with various reasons 11[6]. Resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or reflux. On the other hand, resections close to the pylorus would reduce gastric distensibility and increase intragastric pressure, potentially increasing satiety with less oral intake 11(11,12). The primary aim of this randomized monocentric study is to evaluate %EWL at 1 and 2 years follow-up after LSG in two Groups: Group A with a gastric resection starting from 2 cm from the pylorus with therefore a wide antrectomy and Group B with a gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.

Official Title
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Influence of the Size of the Gastric Antrum After Sleeve Gastrectomy on Weight Loss in Bariatric Surgery

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: Wide antrectomy
* Procedure: Smal antrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: informed consent. morbid obesity defined as body mass index (BMI) 40 kg/m2 Exclusion Criteria: previous bariatric surgical procedures, endocrine disorders causing obesity pregnancy or lactation psychiatric illness inflammatory bowel disease Barrett ́s oesophagus severe GERD with esophagitis B and C a large hiatal hernia (>5 cm) GERD-HRQLscore > 25 dietary restriction despite

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Resection of antrum proximally 2 cm to the pylorus | Procedure: Wide antrectomy<br>* The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.<br>|
| Active Comparator: Group B<br>Resection of antrum proximally 6 cm to the pylorus | Procedure: Smal antrectomy<br>* The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative weight and height combined to report BMI in kg/m^2 | Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2) | 3 months | 
| Postoperative weight and height combined to report BMI in kg/m^2 | Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2) | 6 months | 
| Postoperative weight and height combined to report BMI in kg/m^2 | Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2) | 12 months | 
| Postoperative weight and height combined to report BMI in kg/m^2 | Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2) | 24 months | 
| Postoperative percentage excess weigth loss | Change of weight expressed in percentage of excess weight loss postoperatively at follow-up | 3 months | 
| Postoperative percentage excess weigth loss | Change of weight expressed in percentage of excess weight loss postoperatively at follow-up | 6 months | 
| Postoperative percentage excess weigth loss | Change of weight expressed in percentage of excess weight loss postoperatively at follow-up | 12 months | 
| Postoperative percentage excess weigth loss | Change of weight expressed in percentage of excess weight loss postoperatively at follow-up | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroesophageal reflux disease(GERD) | Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference | at 12 months | 
| Gastroesophageal reflux disease(GERD) | Esophagitys grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference | at 24 months | 
| Gastroesophageal reflux disease symptoms | All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD. | at 3 months | 
| Gastroesophageal reflux disease symptoms | All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD. | at 6 months | 
| Gastroesophageal reflux disease symptoms | All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD. | at 12 months | 
| Gastroesophageal reflux disease symptoms | All patients were surveyed about the presence of heartburn and/or regurgitation with a specific questionnaire GERD HRQL(Gastroesophageal Reflux Disease Health-Related Quality of Life) questionnaire. Each of the 10 questions were rated from 0 (absence of symptoms) to 5 (severe symptoms) for a total score that may range from 0 to 50. Symptoms were defined as absent when patients reported a GERD-HRQL score of 0, mild from 1 to 15, moderate from 16 to 24, and severe from 25 to 50. Patients with GERD-HRQL score >16 was considered positive for GERD. | at 24 months |