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

M

Mansoura University

Status

Completed

Conditions

Obesity

Treatments

Procedure: LSG started 2 cm from the pylorus
Procedure: LSG started 6 cm from pylorus

Study type

Interventional

Funder types

Other

Identifiers

NCT01974388
Morbid Obesity

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 2 patient groups

LSG started 2 cm from the pylorus
Active Comparator group
Description:
laparoscopic sleeve gastrectomy starting 2 cm from the pylorus
Treatment:
Procedure: LSG started 2 cm from the pylorus
LSG started 6 cm from pylorus
Active Comparator group
Description:
LSG started 6 cm from pylorus
Treatment:
Procedure: LSG started 6 cm from pylorus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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