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Completed

NCT Number: NCT01974388

Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayman El Nakeeb

Al Mansurah, Mansoura, 35111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LSG started 2 cm from the pylorus

Procedure

Laparoscopic sleeve gastrectomy started 2 cm from pylorus

Other names: Group I

LSG started 6 cm from pylorus

Procedure

LSG started 6 cm from pylorus

Other names: Group II

Primary outcomes

  1. 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.

Secondary outcomes

  1. length of postoperative stay

    Time frame: 30 days

    length of postoperative stay

  2. 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)

  3. weight regain

    Time frame: one year postoperative

    an increase of body weight of more than 10 kg from the nadir

  4. Resolution of comorbidity

    Time frame: one year postoperative

    Resolution of comorbidity was considered if the disease is controlled without any medications.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: LSG

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2013
Registry last updated
Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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