Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
- Conditions
- Morbid Obesity
- Interventions
- Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypassProcedure: Banded Laparoscopic Roux-en-Y gastric bypass
- Registration Number
- NCT01504685
- Lead Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- body mass index of 40-55 kg/m2
- agreed to participate in this study with informed consent signed
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unbanded laparoscopic gastric bypass Unbanded Laparoscopic Roux- en-Y gastric bypass Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir Banded laparoscopic gastric bypass Banded Laparoscopic Roux-en-Y gastric bypass Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.
- Primary Outcome Measures
Name Time Method Number of participants with postoperative morbidity 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, 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 3,6,9 months and 1,2,5 years identify changes in weight regain during the postoperative 5 years follow up
- Secondary Outcome Measures
Name Time Method