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RCT Comparing OAGB and Long Limb Roux Gastric Bypass

NCT04812132 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-03-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • North Estonia Medical Centre

    collaborator OTHER

  • Fertilitas (private clinic)

    collaborator UNKNOWN

  • Tartu University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2031-12-31
Completion
2036-12-31

Countries

  • Estonia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812132 on ClinicalTrials.gov