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Double-blind randomised controlled study to compare the outcomes of laparoscopic gastric banding and laparoscopic Roux-en-Y gastric bypass in morbidly obese patients attending the Multidisciplinary Morbid Obesity Clinic at King's College Hospital
Source of recordUK Trials
ISRCTNISRCTN33929407
Date ISRCTN assigned30/09/2005
Local reference number(s)N0116140810
Public titleDouble-blind randomised controlled study to compare the outcomes of laparoscopic gastric banding and laparoscopic Roux-en-Y gastric bypass in morbidly obese patients attending the Multidisciplinary Morbid Obesity Clinic at King's College Hospital
Scientific title
AcronymN/A
Disease/condition/study domainNutritional, Metabolic, Endocrine: Obesity
Study hypothesis1. To compare the early outcome (first six months post-operatively) of the two operations with that of a matched group of morbidly obese patients who are on a low calorie diet only (controls)
2. To determine if there is any clinical and statistical difference in the outcomes of the two surgical procedures in the early, medium and long term (up to 5 years post-operatively)
Design/methodologyDouble-blind randomised controlled study
Research ethics reviewNot provided at time of registration
Countries of trialUnited Kingdom
Participants - inclusion criteriaNot provided at time of registration
Participants - exclusion criteriaNot provided at time of registration
Patient information material
Anticipated start date01/09/2003
Anticipated end date01/09/2009
Status of trialOngoing
Target number of participantsNot provided at time of registration
InterventionsT compare the outcomes of laparoscopic gastric banding and laparoscopic Roux-en-Y gastric bypass
Primary outcome measure(s)Not provided at time of registration
Secondary outcome measure(s)Not provided at time of registration
Sources of fundingKings College Hospital NHS Trust R&D Consortium (UK)
NHS R&D support funding
Sponsor nameRecord Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Sponsor detailsThe Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL
Sponsor telephone+44 (0)20 7307 2622
Sponsor emaildhmail@doh.gsi.org.uk
Sponsor websitehttp://www.dh.gov.uk/Home/fs/en
Contact nameMr A G Patel
Contact detailsDepartment of Surgery
King's College Hospital
Denmark Hill
London
United Kingdom
SE5 9RS
Contact telephone+44 (0)20 7346 3065
Contact fax+44
Contact emailameet.patel@kcl.ac.uk
More informationFor more up-to-date information please go to the ISRCTN link below.
Link to record in ISRCTN RegisterISRCTN33929407
Date last extracted from ISRCTN register17/04/2008
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