RCT Comparing OAGB and Long Limb Roux Gastric Bypass
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: One-anastomosis gastric bypass, Long biliary limb Roux gastric bypass.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Estonia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- 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
Primary outcome measures
- Excess weight loss % [Time frame: 10 years]
- Impact on type 2 diabetes mellitus [Time frame: 10 years]
- Impact on type 2 diabetes mellitus [Time frame: 10 years]
- Impact on hypertensive disease [Time frame: 10 years]
- Impact on total cholesterol [Time frame: 10 years]
- Impact on hyperlipidemia [Time frame: 10 years]
- Impact on hyperlipidemia [Time frame: 10 years]
- Impact on hyperlipidemia [Time frame: 10 years]
- Impact on hyperlipidemias [Time frame: 10 years]
Secondary outcome measures (3)
- Nutritional deficiencies: anemia [Time frame: 10 years]
- Nutritional deficiencies [Time frame: 10 years]
- GERD [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- BMI over 35 and obesity related disease
- BMI over 40
- age between 18-60 years
- agrees to participate in the study
Exclusion criteria
- age under 18 years or over 60 years
- abundant adhesions discovered during the surgery
- active upper gastrointestinal ulcer disease
- prior bariatric surgery
- active symptomatic reflux disease
- active psychiatric disease (eg psychosis)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Estonia · 1 center
- Tartu University Hospital — Tartu
Identifiers
NCT: NCT04812132 · TartuUH