Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Banded Laparoscopic Roux-en-Y gastric bypass
* Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index of 40-55 kg/m2 agreed to participate in this study with informed consent signed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unbanded laparoscopic gastric bypass<br>Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir | Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass<br>* 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.<br>* Other names: LRYGB;|
| Active Comparator: Banded laparoscopic gastric bypass<br>Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. | Procedure: Banded Laparoscopic Roux-en-Y gastric bypass<br>* 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.<br>* Other names: banded gastric bypass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative morbidity | determine any morbidity related to the surgical procedure through the 5 years follow up | up to 5 years | 
| Change from Baseline weight assessed at different time points to determine maximal weight loss, | determine changes in weight loss through 5 years follow up, measuring maximal weight loss. | 3,6,9 months and 1,2,5 years | 
| Changes in weight assessed at different time points to determine weight regain | identify changes in weight regain during the postoperative 5 years follow up | 3,6,9 months and 1,2,5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid obesity, Obesity surgery, Gastric bypass, Banded gastric bypass