Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

January 25, 2012 updated by: Miguel F Herrera, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

The purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).

The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is a public health problem that has grown exponentially worldwide. Bariatric surgery has been recognized as the most effective treatment for morbid obesity. However, the debate about the best surgical procedure is still considerable.

Among a wide range of operations that have been used for morbid obesity, Roux-en-Y gastric bypass (RYGB) has shown an appropriate risk/benefit balance and has achieved a high degree of acceptance in America.

The weight loss pattern in RYGB is characteristic and includes significant eight loss during the first 2 years after surgery, followed by some weight regain after the second or third postoperative year. To prevent this some authors suggest the placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. This procedure has been called banded RYGB.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • body mass index of 40-55 kg/m2
  • agreed to participate in this study with informed consent signed

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Unbanded laparoscopic gastric bypass
Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir
Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass

A hand-sewn gastrojejunostomy in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.

To ensure a diameter of 1-1.5 cm,a 32F bougie was used to calibrate the gastro jejunum anastomosis. The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.

Other Names:
  • LRYGB
  • Gastric bypass
Active Comparator: Banded laparoscopic gastric bypass
Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.
Procedure: Banded Laparoscopic Roux-en-Y gastric bypass

A 6.5-cm polypropylene Marlex mesh was placed immediately cephalad to the gastrojejunostomy. The gastrojejunostomy was hand-sewn in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.

The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.

Other Names:
  • BLRYGB
  • banded gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative morbidity
Time Frame: up to 5 years
determine any morbidity related to the surgical procedure through the 5 years follow up
up to 5 years
Change from Baseline weight assessed at different time points to determine maximal weight loss,
Time Frame: 3,6,9 months and 1,2,5 years
determine changes in weight loss through 5 years follow up, measuring maximal weight loss.
3,6,9 months and 1,2,5 years
Changes in weight assessed at different time points to determine weight regain
Time Frame: 3,6,9 months and 1,2,5 years
identify changes in weight regain during the postoperative 5 years follow up
3,6,9 months and 1,2,5 years

Collaborators and Investigators

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

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Miguel F Herrera, MD., PhD, Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"

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

May 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 4, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 25, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • banded/unbandedBypassINNSZ

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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