Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial (LGB-vs-LbGB)

April 18, 2020 updated by: Miguel J. Garcia-Oria, Puerta de Hierro University Hospital

Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial

This study try to identify differences in length of operation, weight loss and complications, between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the laparoscopic Roux-en-Y banded gastric bypass. The study will be conducted in a Spanish public health system hospital. The patients of the trial will have the preoperative studies, hospital treatment during the admission, postoperative treatment and follow up as any other patient included in the hospital bariatric surgery program. The study cases will have placed around the gastric pouch a band of polypropylene mesh, and will be randomly choose between the participants.

Patients will be randomized in a 5/3 (study/control) ratio.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

One group of patients of the study will have done the simplified laparoscopic gastric bypass, with a vertical gastric pouch of about 20 ml, a 150 cm Roux-en-Y limb constructed in an antegastric antecolic fashion, and a biliary limb of 100 cm. Anastomosis will be done with endoscopic surgical linear stapler, closing the apertures with continuous absorbable running sutures. The Petersen space and the mesenteric defect will be closed with non-absorbable sutures.

The other group of patients will have performed the laparoscopic Roux-en-Y banded gastric bypass. This technique is identical to the one performed in the other group, but differs in that a polypropylene mesh (10x65 mm) is placed 15 mm proximal to the anastomosis around the gastric pouch, and the gastric pouch is about 15 mm longer.

The investigators randomly assigned 50 patients to the study group (Laparoscopic Roux-en-Y banded gastric bypass) and 30 to the control group (Laparoscopic Roux-en-Y gastric bypass) , n=80, and were also blinded to the surgeon until surgery.

One of the methods is basically the same than the other, but for the placement of the polypropylene mesh around the gastric pouch above the anastomosis, and patient series with Laparoscopic Roux-en-Y banded gastric bypass showed long term better weight loss than other series with not banded gastric bypass, thus it is expected a difference in long term weight loss between groups.

Fisher Test will be used for the statistical analysis, assuming a risk of 0.05 and a statistical power of 90%.

Sample size is calculated considering bibliographic long term weight loss in both groups, which is 82% in the banded group versus 63% in the not banded group. Thus sample size (n): 67, and adjust by loss sample size: 79 (10% expected loss ratio), not being necessary a 1: 1 ratio between cases and controls and requiring no more than 25 controls, A sample size of 50 cases and 30 controls, total n = 80, will be used.

The method of randomization was concealed envelopes.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda

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:

  • criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
  • Body mass index (BMI)> 40 and <55 kg/m2
  • Obesity for more than 5 years of evolution
  • Fail in medical supervised weight loss program
  • patient knowing of the mechanism of weight loss after surgery and agreement to collaborate with medical recommendations, diet, medical treatment, as well as the visit established in the follow up program
  • patient accepting that surgery objective is not to achieve the ideal weight.
  • signed specific informed consent
  • women will agree in avoid gestation during one year after surgery

Exclusion Criteria:

  • Patients unable to sign the informed consent form because of a mental disorder.
  • endocrine diseases causing obesity
  • unstable mental disorder, evaluated for a psychiatry MD.
  • high anesthetic risk making surgery too risky.
  • Malignant neoplasm
  • Inflammatory bowel disease
  • Severe liver disease
  • Digestive disease that makes unwise the bypass technique (mainly gastric illness that may required upper endoscopy for control)
  • abdominal wall hernias
  • Symptomatic biliary pathology that requires cholechistectomy at the same time of the bariatric surgery
  • any known pathology that requieres or recomend simultaneous surgery at the time of the bariatric surgery.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Banded Gastric Bypass
The patient will have done a laparoscopic Roux-en-Y banded (with polypropylene mesh) gastric bypass at the time of the surgical procedure.
Device: Banded (with polypropylene mesh) gastric bypass
The patient will be submitted to a Laparoscopic Roux-en-Y banded gastric bypass at the time of the operation, with a polypropylene mesh around the gastric pouch.
Other Names:
  • Laparoscopic banded gastric bypass
  • Laparoscopic Roux-en-Y banded gastric bypass
  • Laparoscopic Banded Roux-en-Y gastric bypass
Active Comparator: Gastric Bypass.
The patient will have done a Laparoscopic Roux-en-Y gastric bypass at the time of the surgical procedure
Procedure: Gastric bypass
In this case a simplified conventional gastric bypass will be performed
Other Names:
  • Laparoscopic Gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from operation date, in excess weight loss at 10 years
Time Frame: 10 years
% of excess weight loss at 10 years
10 years
Postoperative complications at 10 years
Time Frame: 10 years
Number of participants with adverse events (surgical complications) and/or abnormal Laboratory values that are related to treatment
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excess weight loss at 5 years
Time Frame: 5 years
% of excess weight loss at 5 years
5 years
Total Hospital cost at 3 months
Time Frame: up to 3 months
Total hospital expenses during admission for the surgery and 3 months after the operation.
up to 3 months
Postoperative complications 1 year
Time Frame: 1 year
Number of participants with adverse events (surgical complications)
1 year
Postoperative complications 2 years
Time Frame: 2 years
Number of participants with adverse events (surgical complications)
2 years
Postoperative complications 3 years
Time Frame: 3 years
Number of participants with adverse events (surgical complications)
3 years
Postoperative complications 5 years
Time Frame: 5 years
Number of participants with adverse events (surgical complications)
5 years

Collaborators and Investigators

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

Sponsor

Puerta de Hierro University Hospital

Investigators

  • Study Chair: Miguel J Garcia-Oria, MD PhD FACS, General Surgery Department. Hospital Universitario Puerta de Hierro
  • Study Director: Miguel J Garcia-Oria, MD PhD, Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2016

Primary Completion (Anticipated)

January 1, 2034

Study Completion (Anticipated)

January 1, 2034

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 18, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04252016Acta07.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will publish the results of the study in a surgical journal

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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