Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy (LSG)

November 20, 2015 updated by: Ayman El Nakeeb, Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35111
        • Ayman El Nakeeb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LSG started 2 cm from the pylorus
laparoscopic sleeve gastrectomy starting 2 cm from the pylorus
Procedure: LSG started 2 cm from the pylorus
Laparoscopic sleeve gastrectomy started 2 cm from pylorus
Other Names:
  • Group I
Active Comparator: LSG started 6 cm from pylorus
Procedure: LSG started 6 cm from pylorus
LSG started 6 cm from pylorus
Other Names:
  • Group II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent of excess weight loss
Time Frame: one year postoperative
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
Time Frame: 30 days
length of postoperative stay
30 days
postoperative complications
Time Frame: 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)
one year postoperative
weight regain
Time Frame: one year postoperative
an increase of body weight of more than 10 kg from the nadir
one year postoperative
Resolution of comorbidity
Time Frame: one year postoperative
Resolution of comorbidity was considered if the disease is controlled without any medications.
one year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

October 26, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 20, 2015

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Morbid Obesity

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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