Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery (OPTIMIZE)

Medtronic

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: Gastric Sleeve Resection; Procedure: Roux-en-Y Gastric Bypass

Study type: Observational

Funder types: Industry

Identifiers

NCT01754194

COVMBSG0167

Details and patient eligibility

About

Study objectives:

1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery
2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

Full description

The objectives of this study are the following: to generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery; and to support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

Enrollment: 293 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients aged from 18 to 65 years of age, inclusive
• BMI > 40 or BMI > 35 with co-morbidities
• Eligible for weight-loss surgery
• Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery
• Insurance approval status: approved
• Written informed consent

Exclusion criteria

• BMI > 55
• Planned two-stage procedures
• Prior bariatric procedures (including gastric banding)
• Serious mental or physical co-morbidities at the discretion of the Investigator
• Insurance approval status: rejected

Trial design

293 participants in 2 patient groups

Procedure Type 1

Description:

Gastric Sleeve Resection

Treatment:

Procedure: Gastric Sleeve Resection

Procedure Type 2

Description:

Roux-en-Y Gastric Bypass

Treatment:

Procedure: Roux-en-Y Gastric Bypass