Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/10/2010
Date assigned
24/11/2010
Last edited
13/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jakob Hedberg

ORCID ID

Contact details

Department of Surgical Sciences
Uppsala University
Uppsala
75185
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ups 03-456

Study information

Scientific title

Duodenal switch versus gastric bypass in patients with a body mass index (BMI) greater than 48 kg/m^2: a prospective randomised controlled trial

Acronym

DS vs RYGBP

Study hypothesis

Super-obese patients (body mass index [BMI] greater than 50 kg/m^2) have lower success-rate in terms of weight loss than obese (BMI 40 - 50 kg/m^2). Previous studies have shown greater weight loss after duodenal switch. We want to study weight loss, safety, and post-operative symptoms after these two operations in a randomised trial.

Ethics approval

The Regional Ethical Review Board at the University of Uppsala approved on the 19th October 2003

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

Biliopancreatic diversion with duodenal switch (DS) versus Roux-en-Y Gastic bypass (RYGBP). The aim is to compare perioperative safety as well as long term effects on weight, comorbidities and gastrointestinal symptoms. Follow up is made at three years after surgery, and long term follow up at ten years is planned.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Weight result, measured at 3 years
2. Peri-operative safety, collected at the time of surgery

Secondary outcome measures

1. Gastrointestinal symptoms, measured at 3 years
2. Long-term surgical complications, measured at 3 years
3. Metabolical evaluation, measured at 3 years
4. Overall satisfaction, measured at 3 years

Overall trial start date

01/01/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (aged over 18 years, either sex) with BMI greater than 48 kg/m^2 referred for bariatric surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Language difficulties
2. Previous problems of diarrhoea
3. Suspected inflammatory bowel disease

Recruitment start date

01/01/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Surgical Sciences
Uppsala
75185
Sweden

Sponsor information

Organisation

Uppsala University (Sweden)

Sponsor details

-
Uppsala
75185
Sweden

Sponsor type

University/education

Website

http://www.uu.se/en/

Funders

Funder type

University/education

Funder name

Uppsala University (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22425057

Publication citations

  1. Results

    Hedberg J, Sundbom M, Superior weight loss and lower HbA1c 3 years after duodenal switch compared with Roux-en-Y gastric bypass--a randomized controlled trial., Surg Obes Relat Dis, 8, 3, 338-343, doi: 10.1016/j.soard.2012.01.014.

Additional files

Editorial Notes