Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial (LGB-vs-LbGB)
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|ClinicalTrials.gov Identifier: NCT02939664|
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2016
Last Update Posted : October 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity Weight Loss Postoperative Complications||Device: Banded (with polypropylene mesh) gastric bypass Procedure: Gastric bypass||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||January 2034|
|Estimated Study Completion Date :||January 2034|
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.
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 Name: Laparoscopic Gastric bypass
- Change from operation date, in excess weight loss at 10 years [ Time Frame: 10 years ]% of excess weight loss at 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
- Excess weight loss at 5 years [ Time Frame: 5 years ]% of excess weight loss at 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.
- Postoperative complications 1 year [ Time Frame: 1 year ]Number of participants with adverse events (surgical complications)
- Postoperative complications 2 years [ Time Frame: 2 years ]Number of participants with adverse events (surgical complications)
- Postoperative complications 3 years [ Time Frame: 3 years ]Number of participants with adverse events (surgical complications)
- Postoperative complications 5 years [ Time Frame: 5 years ]Number of participants with adverse events (surgical complications)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939664
|Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda|
|Majadahonda, Madrid, Spain, 28222|
|Study Chair:||Victor Sánchez Turrion, MD PhD FACS||Chairman. 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|