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
| ISRCTN | ISRCTN33929407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33929407 |
| Secondary identifying numbers | N0116140810 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 30/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr A G Patel
Scientific
Scientific
Department of Surgery
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)20 7346 3065 |
|---|---|
| ameet.patel@kcl.ac.uk |
Study information
| Study design | Double-blind randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Obesity |
| Intervention | T compare the outcomes of laparoscopic gastric banding and laparoscopic Roux-en-Y gastric bypass |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2003 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Surgery
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Kings College Hospital NHS Trust R&D Consortium (UK)
No information available
NHS R&D support funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
30/04/2018: No publications found, verifying study status with principal investigator.
09/03/2016: No publications found, verifying study status with principal investigator.
