NCT04812132

RCT Comparing OAGB and Long Limb Roux Gastric Bypass

A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Tartu University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea. Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life. There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts. There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	One-anastomosis gastric bypass	One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
PROCEDURE	Long biliary limb Roux gastric bypass	Other group is planned to receive a long biliary limb Roux gastric bypass

Timeline

• Start date: 2021-01-01
• Primary completion: 2031-12-31
• Completion: 2036-12-31
• First posted: 2021-03-23
• Last updated: 2021-03-23

Locations

1 site across 1 country: Estonia