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

NCT ID: NCT01514799

Last Updated: 2020-02-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-29

Study Completion Date

2020-02-01

Brief Summary

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Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.

The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.

Endpoints are quality of life, gastrointestinal function, and weight development.

Detailed Description

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Two variations of gastric bypass are compared:

Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.

Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.

FU time is set at 5 years.

Conditions

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Morbid Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised study between long and standard biliopancreatic limb in gstric bypass surgery
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Randomisation in the OR, (closed envelopes, blocks of six) no further info to ward or follow-up unit. No specific info as to randomisation outcome given to patients, all patients follow same protocol.

Code number in operative charts.

Study Groups

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standard length bp limb, long alimentary limb

our normal way of doing a gastric bypass 60 cm BP limb

Group Type ACTIVE_COMPARATOR

gastric bypass

Intervention Type PROCEDURE

two techniques of gastric bypass for studying the effects of making a long BP-limb

Long BP limb

200 cm BP limb

Group Type EXPERIMENTAL

gastric bypass

Intervention Type PROCEDURE

two techniques of gastric bypass for studying the effects of making a long BP-limb

Interventions

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gastric bypass

two techniques of gastric bypass for studying the effects of making a long BP-limb

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI 50-65
* Age 18-55
* Conservative attempts at weight reduction failed

Exclusion Criteria

* Inability to speak and understand the Swedish language
* Residence outside the county of Skåne
* Psychotic disease
* Inflammatory bowel disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aleris Obesity

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan L Hedenbro

Role: PRINCIPAL_INVESTIGATOR

Lunds Universitets Diabetescentrum

Locations

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Aleris Obesity Skåne

Lund, , Sweden

Site Status

Countries

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Sweden

References

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Nergard BJ, Leifson BG, Gislason H, Hedenbro JL. Effect of different limb lengths on quality of life, eating patterns and gastrointestinal symptoms after Roux-en-Y gastric bypass in superobese patients: randomized study. BJS Open. 2020 Sep 15;4(6):1109-16. doi: 10.1002/bjs5.50334. Online ahead of print.

Reference Type DERIVED
PMID: 32931641 (View on PubMed)

Nergard BJ, Lindqvist A, Gislason HG, Groop L, Ekelund M, Wierup N, Hedenbro JL. Mucosal glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide cell numbers in the super-obese human foregut after gastric bypass. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1237-46. doi: 10.1016/j.soard.2015.03.021. Epub 2015 Apr 2.

Reference Type DERIVED
PMID: 26143297 (View on PubMed)

Other Identifiers

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2011_HG_Aleris_limb_length

Identifier Type: -

Identifier Source: org_study_id

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