Contact information
Type
Scientific
Primary contact
Mr A G Patel
ORCID ID
Contact details
Department of Surgery
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 7346 3065
ameet.patel@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0116140810
Study information
Scientific title
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
Acronym
Study hypothesis
1. 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)
Ethics approval
Not provided at time of registration
Study design
Double-blind randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Obesity
Intervention
T compare the outcomes of laparoscopic gastric banding and laparoscopic Roux-en-Y gastric bypass
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2003
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2003
Recruitment end date
01/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Kings College Hospital NHS Trust R&D Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D support funding
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