Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy

Study Overview
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Brief Summary
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Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by both restrictive and hormonal action. Consecutive patients with morbid obesity treated by LSG at our department were evaluated. Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

Detailed Description
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This prospective randomized study was designed to compare between the beginning of sleeve gastrectomy 2 cm versus 6 cm from the pylorus with special regards to intraoperative problems, weight loss, improvement of comorbidities, postoperative complications, nutritional and elemental deficiencies. Consecutive patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG) at the department of general surgery, Mansoura University, Egypt, during the period from January 2008 to January 2012, were eligible for the study. The exclusion criteria included patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse. The operation was done under general anesthesia. Patient was in supine position with splitting of the operating table legs.Gastric transection started 2 cm proximal to the pylorus using 60 mm, green endo-stapler (Ethicon, USA) (GI) or 6 cm from the pylorus (G II). The following staplers were placed approximately 1 cm from the bougie in the direction of the gastroesophageal junction. Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

Official Title
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Impact of Extent of Antral Resection on Surgical Outcomes of Sleeve Gastrectomy for Morbid Obesity (A Prospective Randomized Study)

Conditions
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Obesity

Intervention / Treatment
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* Procedure: LSG started 2 cm from the pylorus
* Procedure: LSG started 6 cm from pylorus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG) Exclusion Criteria: patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LSG started 2 cm from the pylorus<br>laparoscopic sleeve gastrectomy starting 2 cm from the pylorus | Procedure: LSG started 2 cm from the pylorus<br>* Laparoscopic sleeve gastrectomy started 2 cm from pylorus<br>* Other names: Group I;|
| Active Comparator: LSG started 6 cm from pylorus<br>LSG started 6 cm from pylorus | Procedure: LSG started 6 cm from pylorus<br>* LSG started 6 cm from pylorus<br>* Other names: Group II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of excess weight loss | The percent of EWL was calculated as follows: [(preoperative weight-follow up weight)/preoperative excess weight] ×100. | one year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of postoperative stay | length of postoperative stay | 30 days | 
| postoperative complications | gastric leakage, internal haemorrhage, pulmonary complications). Complications were graded according to their severity on a validated five point scale using Dindo-Clavien complication classification system) into (grades I, II, IIIa-b, IVa-b, V). Grade I (no need for specific intervention), grade II (need for drug therapy such antibiotics, blood transfusion, total parenteral nutrition), grade IIIa-b (need for invasive therapy radiological, endoscopic or surgical), grade IVa-b (organ dysfunction requiring ICU stay and management), grade V (death) | one year postoperative | 
| weight regain | an increase of body weight of more than 10 kg from the nadir | one year postoperative | 
| Resolution of comorbidity | Resolution of comorbidity was considered if the disease is controlled without any medications. | one year postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric surgery, sleeve gastrectomy, gastric leak