Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: LSG started 2 cm from the pylorus; Procedure: LSG started 6 cm from pylorus

• Registration Number: NCT01974388
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2008-01
• Study Start: 2008-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-26
• Study First Posted: 2013-11-01
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LSG started 2 cm from the pylorus	LSG started 2 cm from the pylorus	laparoscopic sleeve gastrectomy starting 2 cm from the pylorus
LSG started 6 cm from pylorus	LSG started 6 cm from pylorus	LSG started 6 cm from pylorus

Primary Outcome Measures

Name	Time	Method
percent of excess weight loss	one year postoperative	The percent of EWL was calculated as follows: \[(preoperative weight-follow up weight)/preoperative excess weight\] ×100.

Secondary Outcome Measures

Name	Time	Method
length of postoperative stay	30 days	length of postoperative stay
postoperative complications	one year postoperative	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)
weight regain	one year postoperative	an increase of body weight of more than 10 kg from the nadir
Resolution of comorbidity	one year postoperative	Resolution of comorbidity was considered if the disease is controlled without any medications.

Trial Locations

Locations (1)

Ayman El Nakeeb; 🇪🇬 Mansoura, Egypt