Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01504685|
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : January 26, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Procedure: Banded Laparoscopic Roux-en-Y gastric bypass Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||August 2010|
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.
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.
- 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
- 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.
- 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
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): NCT01504685
|Principal Investigator:||Miguel F Herrera, MD., PhD||Instituto Nacional de Ciencias Medicas y Nutrición "Salavador Zubirán"|