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

Primary Purpose

Morbid Obesity, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

gastric bypass

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring gastric bypass, morbid obesity, gut function, weight loss

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aleris Obesity Skåne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard length bp limb, long alimentary limb

Long BP limb

Arm Description

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

200 cm BP limb

Outcomes

Primary Outcome Measures

body weight reduction

absolute BW reduction, percentage of patients reaching BMI below 30,

Secondary Outcome Measures

gastrointestinal function

SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables

Full Information

NCT ID

NCT01514799

First Posted

January 18, 2012

Last Updated

February 24, 2020

Sponsor

Aleris Obesity

1. Study Identification

Unique Protocol Identification Number

NCT01514799

Brief Title

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

Official Title

Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

August 29, 2011 (Actual)

Primary Completion Date

November 20, 2015 (Actual)

Study Completion Date

February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aleris Obesity

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity, Weight Loss

Keywords

gastric bypass, morbid obesity, gut function, weight loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

InvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard length bp limb, long alimentary limb

Arm Type

Active Comparator

Arm Description

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

Arm Title

Long BP limb

Arm Type

Experimental

Arm Description

200 cm BP limb

Intervention Type

Procedure

Intervention Name(s)

gastric bypass

Intervention Description

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

Primary Outcome Measure Information:

Title

body weight reduction

Description

absolute BW reduction, percentage of patients reaching BMI below 30,

Time Frame

5 years

Secondary Outcome Measure Information:

Title

gastrointestinal function

Description

SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan L Hedenbro

Organizational Affiliation

Lunds Universitets Diabetescentrum

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aleris Obesity Skåne

City

Lund

ZIP/Postal Code

SE 222 70

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

32931641

Citation

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.

Results Reference

derived

PubMed Identifier

26143297

Citation

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.

Results Reference

derived

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

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