NCT00632593

Brief Summary

The purpose of this study is to define and evaluate the early complications between two different surgical techniques used to perform a laparoscopic gastric bypass

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
Last Updated

March 10, 2008

Status Verified

February 1, 2008

Enrollment Period

1.8 years

First QC Date

February 28, 2008

Last Update Submit

March 7, 2008

Conditions

Obesity

Keywords

Early Complications of both techniquesFistula rateDehiscence ratereoperation rate and cause

Study Arms (2)

Circular Stapled

ACTIVE COMPARATOR

Patients operated performing the gastric pouch of the gastric bypass with a circular staple device

Procedure: Laparoscopic Gastric Bypass

Handsewn anastomosis

ACTIVE COMPARATOR

Patients operated performing the gastric pouch of the gastric bypass in a handsewn manner

Procedure: Laparoscopic Gastric Bypass

Interventions

Laparoscopic Gastric BypassPROCEDURE
Circular Stapled

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass Index between 35 with comorbidities and 50 kg/mt2

You may not qualify if:

  • Body mass index \<35kg7mt2 and \>50kg/mt2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Of Bellvitge

Barcelona, Catalonia, 08907, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leonardo J Silvio, MD

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 10, 2008

Study Start

March 1, 2005

Primary Completion

January 1, 2007

Study Completion

May 1, 2007

Last Updated

March 10, 2008

Record last verified: 2008-02

Locations

ES(1)