Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2021-01-01
2036-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Women
One-anastomosis gastric bypass
One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
Long biliary limb Roux gastric bypass
Other group is planned to receive a long biliary limb Roux gastric bypass
Men
One-anastomosis gastric bypass
One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
Long biliary limb Roux gastric bypass
Other group is planned to receive a long biliary limb Roux gastric bypass
Interventions
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One-anastomosis gastric bypass
One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
Long biliary limb Roux gastric bypass
Other group is planned to receive a long biliary limb Roux gastric bypass
Eligibility Criteria
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Inclusion Criteria
* BMI over 40
* age between 18-60 years
* agrees to participate in the study
Exclusion Criteria
* abundant adhesions discovered during the surgery
* active upper gastrointestinal ulcer disease
* prior bariatric surgery
* active symptomatic reflux disease
* active psychiatric disease (eg psychosis)
18 Years
60 Years
ALL
No
Sponsors
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North Estonia Medical Centre
OTHER
Fertilitas (private clinic)
UNKNOWN
Tartu University Hospital
OTHER
Responsible Party
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Eva-Maria Kikkas
Doctor and Teaching staff
Locations
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Tartu University Hospital
Tartu, , Estonia
Countries
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Facility Contacts
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Other Identifiers
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TartuUH
Identifier Type: -
Identifier Source: org_study_id
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