Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study

NCT ID: NCT02033577

Last Updated: 2015-03-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-08-31

Brief Summary

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Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.

Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.

Detailed Description

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Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.

Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.

Conditions

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Severe Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Distal gastrojejunal bypass

RYGB with 200 cm BP limb and 150 cm common limb

Group Type EXPERIMENTAL

Distal gastrojejunal bypass

Intervention Type PROCEDURE

RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications

RYGB

RYGB with 60 cm BP limb and 150 cm alimentary limb

Group Type ACTIVE_COMPARATOR

RYGB

Intervention Type PROCEDURE

RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on

Interventions

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Distal gastrojejunal bypass

RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications

Intervention Type PROCEDURE

RYGB

RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \> 50

Exclusion Criteria

* Psychiatric disease
* Inflammatory bowel disease
* inability to understand Swedish
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Aleris Obesity

INDUSTRY

Sponsor Role lead

Responsible Party

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Jan Hedenbro

Senior scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aleris Obesity

Lund, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Jan Hedenbro, MD,PhD

Role: CONTACT

+46705132572

Hjortur G Gislason, MD,PhD

Role: CONTACT

+4748891375

Facility Contacts

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Bent Johnny Nergaard, MD

Role: primary

+4792861730

Jan Hedenbro

Role: backup

Other Identifiers

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NCT01514799

Identifier Type: -

Identifier Source: org_study_id

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