NCT02033577

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

January 9, 2014

Last Update Submit

March 16, 2015

Conditions

Severe Obesity

Outcome Measures

Primary Outcomes (1)

  • Body weight reduction

    Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.

    2 years from end of inclusion

Secondary Outcomes (1)

  • Patient assessed quality of life

    2 years from end of inclusion

Other Outcomes (1)

  • Short-term complications

    0-30 days postoperatively

Study Arms (2)

Distal gastrojejunal bypass

EXPERIMENTAL

RYGB with 200 cm BP limb and 150 cm common limb

Procedure: Distal gastrojejunal bypass

RYGB

ACTIVE COMPARATOR

RYGB with 60 cm BP limb and 150 cm alimentary limb

Procedure: RYGB

Interventions

Distal gastrojejunal bypassPROCEDURE

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

Distal gastrojejunal bypass
RYGBPROCEDURE

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

RYGB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 50

You may not qualify if:

  • Psychiatric disease
  • Inflammatory bowel disease
  • inability to understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleris Obesity

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jan Hedenbro, MD,PhD

CONTACT

+46705132572jan.hedenbro@aleris.se

Hjortur G Gislason, MD,PhD

CONTACT

+4748891375hjortur.gislason@aleris.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior scientist

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

August 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

SE(1)