NCT01504685

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-03-01
• Completion: 2010-08-01
• First posted: 2012-01-05
• Last updated: 2012-01-26