NCT01754194

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

An Observational Study in Morbidly Obese Patients to Evaluate Laparoscopic Gastric Sleeve Resections and Roux-en-Y Gastric Bypass Surgery in Clinical and Health-Economic Terms

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 293 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
PROCEDURE	Gastric Sleeve Resection	Laparoscopic Gastric Sleeve Resection
PROCEDURE	Roux-en-Y Gastric Bypass	Laparoscopic Roux-en-Y Gastric Bypass

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-09-01
• Completion: 2014-10-01
• First posted: 2012-12-21
• Last updated: 2017-07-07
• Results posted: 2017-07-07

Locations

18 sites across 1 country: Germany