Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

Morbid Obesity Clinical Trial

Official title:

Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793728
• Other study ID #: PR131/08
• Status: Completed
• Phase: N/A
• First received: November 18, 2008
• Last updated: August 19, 2015
• Start date: October 2008
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

This study compares if there is any difference doing antrectomy while performing a sleeve gastrectomy for treating morbid obesity. The investigators compare the differences between leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI>40 kg/m2

• Age >18 years old

• Eligible for laparoscopic surgery

Exclusion Criteria:

• Prior bariatric surgery

• Sleeve gastrectomy as a part of a duodenal switch

• Second time surgery before 18 months

• Other procedures done during the surgery

• Conversion to laparotomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Sleeve gastrectomy
Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight lose		One year	Yes
Primary	Food tolerance		One year	Yes
Primary	Quality of life		One year	No
Secondary	Metabolic syndrome outcome		One year	No