NCT01514799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2015

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

4.2 years

First QC Date

January 18, 2012

Last Update Submit

February 24, 2020

Conditions

Morbid ObesityWeight Loss

Keywords

gastric bypassmorbid obesitygut functionweight loss

Outcome Measures

Primary Outcomes (1)

  • body weight reduction

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

    5 years

Secondary Outcomes (1)

  • gastrointestinal function

    5 years

Study Arms (2)

standard length bp limb, long alimentary limb

ACTIVE COMPARATOR

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

Procedure: gastric bypass

Long BP limb

EXPERIMENTAL

200 cm BP limb

Procedure: gastric bypass

Interventions

gastric bypassPROCEDURE

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

Long BP limbstandard length bp limb, long alimentary limb

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inability to speak and understand the Swedish language
  • Residence outside the county of Skåne
  • Psychotic disease
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleris Obesity Skåne

Lund, SE 222 70, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 32931641DERIVED

  • 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.

    PMID: 26143297DERIVED

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Jan L Hedenbro

    Lunds Universitets Diabetescentrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised study between long and standard biliopancreatic limb in gstric bypass surgery
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 23, 2012

Study Start

August 29, 2011

Primary Completion

November 20, 2015

Study Completion

February 1, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

SE(1)