RCT Comparing OAGB and Long Limb Roux Gastric Bypass

NCT ID: NCT04812132

Last Updated: 2021-03-23

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2036-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Women

Group Type ACTIVE_COMPARATOR

One-anastomosis gastric bypass

Intervention Type PROCEDURE

One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)

Long biliary limb Roux gastric bypass

Intervention Type PROCEDURE

Other group is planned to receive a long biliary limb Roux gastric bypass

Men

Group Type ACTIVE_COMPARATOR

One-anastomosis gastric bypass

Intervention Type PROCEDURE

One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)

Long biliary limb Roux gastric bypass

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Long biliary limb Roux gastric bypass

Other group is planned to receive a long biliary limb Roux gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Estonia Medical Centre

OTHER

Sponsor Role collaborator

Fertilitas (private clinic)

UNKNOWN

Sponsor Role collaborator

Tartu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eva-Maria Kikkas

Doctor and Teaching staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tartu University Hospital

Tartu, , Estonia

Site Status RECRUITING

Countries

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Estonia

Facility Contacts

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Eva-Maria Kikkas, Dr

Role: primary

+37258162720

Toomas Sillakivi, Dr, PhD

Role: backup

Other Identifiers

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TartuUH

Identifier Type: -

Identifier Source: org_study_id

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