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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass; Procedure: Banded Laparoscopic Roux-en-Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01504685

banded/unbandedBypassINNSZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• body mass index of 40-55 kg/m2
• agreed to participate in this study with informed consent signed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Unbanded laparoscopic gastric bypass

Active Comparator group

Description:

Laparoscopic Roux- en-Y gastric bypass without any band around de gastric reservoir

Treatment:

Procedure: Unbanded Laparoscopic Roux- en-Y gastric bypass

Banded laparoscopic gastric bypass

Active Comparator group

Description:

Placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy.

Treatment:

Procedure: Banded Laparoscopic Roux-en-Y gastric bypass