Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity

Medical University of Warsaw

Status: Completed

Conditions: Hypertension; Diabetes Mellitus; Dyslipidemia; Morbid Obesity; Metabolic Syndrome X

Treatments: Procedure: Laparoscopic sleeve gastrectomy; Procedure: Roux-en-Y Gastric Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01806506

KBN N N403 3882 33

Details and patient eligibility

About

Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.

Full description

Authors of the study believe that a more detailed head-to-head comparison of RYGB and LSG is necessary. The former method is the established "gold standard" procedure with good outcomes reported in many studies. However it is much more complex and the learning curve is longer. The latter method was introduced as an initial procedure in superobese patients because of its relative simplicity. It produced good outcomes in this population of superobese patients and surgeons in some centers started to use it as a primary bariatric procedure. RYGB is a restrictive and partially malabsorptive procedure and it is believed to have additional benefits in patients with metabolic disorders such as type 2 diabetes and dyslipidemia. Purely restrictive procedures such as LSG are theoretically less beneficial in this group of patients. In the present study authors will look at weight loss as well as improvement in comorbidities and several biochemical parameters and indices to assess also metabolic action of these two procedures.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI≥40 kg/m2
• BMI≥35 kg/m2 with at least one comorbidity associated with obesity

Exclusion criteria

• BMI > 60 kg/m2
• poorly controlled significant medical or psychiatric disorders
• active alcohol or substance abuse
• active duodenal/gastric ulcer disease
• difficult to treat gastro-esophageal reflux disease with a large hiatal hernia
• previous major gastrointestinal surgery
• diagnosed or suspected malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Laparoscopic sleeve gastrectomy

Experimental group

Description:

The group of morbidly obese patients assigned to laparoscopic sleeve gastrectomy.

Treatment:

Procedure: Laparoscopic sleeve gastrectomy

Roux-en-Y Gastric Bypass

Experimental group

Description:

The group of morbidly obese patients assigned to Roux-en-Y gastric bypass.

Treatment:

Procedure: Roux-en-Y Gastric Bypass