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

NCT02939664 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-04-21

No results posted yet for this study

Summary

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.

Conditions

  • Morbid Obesity
  • Weight Loss
  • Postoperative Complications

Interventions

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.

PROCEDURE

Gastric bypass

In this case a simplified conventional gastric bypass will be performed

Sponsors & Collaborators

  • Puerta de Hierro University Hospital

    lead OTHER

Principal Investigators

  • Miguel J Garcia-Oria, MD PhD FACS · General Surgery Department. Hospital Universitario Puerta de Hierro

  • Miguel J Garcia-Oria, MD PhD · Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2034-01-31
Completion
2034-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02939664 on ClinicalTrials.gov