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

ISRCTN	ISRCTN10940791
DOI	https://doi.org/10.1186/ISRCTN10940791
Protocol serial number	Ups 03-456
Sponsor	Uppsala University (Sweden)
Funder	Uppsala Universitet

Submission date: 15/10/2010
Registration date: 24/11/2010
Last edited: 17/08/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jakob Hedberg
Scientific

Department of Surgical Sciences
Uppsala University
Uppsala
75185
Sweden

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	DS vs RYGBP
Study objectives	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(s)	The Regional Ethical Review Board at the University of Uppsala approved on the 19th October 2003
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Weight result, measured at 3 years 2. Peri-operative safety, collected at the time of surgery
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Total final enrolment	47
Key inclusion criteria	Patients (aged over 18 years, either sex) with BMI greater than 48 kg/m^2 referred for bariatric surgery
Key exclusion criteria	1. Language difficulties 2. Previous problems of diarrhoea 3. Suspected inflammatory bowel disease
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Surgical Sciences

Uppsala
75185
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No
Results article	Long-term follow-up	16/08/2023	17/08/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/08/2023: Publication reference and total final enrolment added.