A prospective cohort study of laparoscopic sleeve gastrectomy for weight loss in obese patients on haemodialysis: proof of concept
| ISRCTN | ISRCTN24299618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24299618 |
| Secondary identifying numbers | 10025 |
- Submission date
- 21/06/2011
- Registration date
- 21/06/2011
- Last edited
- 18/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Helen MacLaughlin
Scientific
Scientific
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Study design | Non-randomised, interventional, treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A prospective cohort study of laparoscopic sleeve gastrectomy for weight loss in obese patients on haemodialysis: proof of concept |
| Study objectives | Obesity can cause chronic kidney disease and lead to kidney failure. However, obese patients are less likely to be eligible for kidney transplantation - the best treatment option for patients with kidney failure. Weight loss surgery is an effective treatment for weight loss but has not yet been studied systematically in patients with kidney failure. This research aims to find out whether weight loss surgery is an effective and safe treatment for obesity in patients with kidney failure on haemodialysis. |
| Ethics approval(s) | 10/H0716/55 |
| Health condition(s) or problem(s) studied | Renal and Urogenital |
| Intervention | 1. 15 volunteer haemodialysis patients with a body mass index > 35 will have keyhole surgery to reduce the size of their stomach to limit food intake and hunger. 2. The weight loss surgery procedure selected is the sleeve gastrectomy 3. In this operation, the size of the stomach is permanently reduced to one-third of its original size by removing some of the stomach to form a smaller, tube shaped stomach. 4. Another 15 patients with a body mass index >35 who choose not to have keyhole surgery will also be studied as a comparison group 5. Weight loss, achieving the body mass index criteria for listing for kidney transplantation, quality of life, changes in blood pressure and blood fats and the safety of the operation will be measured over 1 year |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Orlistat |
| Primary outcome measure | 1. BMI <35 kg/m2 2. Measured at timepoint(s) of 6 and 12 months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 07/02/2011 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 30; UK Sample Size: 30 |
| Key inclusion criteria | 1. On haemodialysis for at least 90 days 2. Male or female, aged > 18 years 3. BMI > 35 kg/m2 4. Previously attempted weight loss (surgery arm only) 5. Fit for anesthesia and surgery (surgery arm only) 6. Written informed consent |
| Key exclusion criteria | 1. Pregnancy 2. History of chronic liver disease 3. Previous bariatric surgery, gastric surgery or large hiatus hernia 4.Psychiatric illness, including anxiety, mood and untreated eating disorders 5. Malnutrition (assessed by subjective global assessment) 6. Infection or course of antibiotics within the last month 7. Peritoneal dialysis |
| Date of first enrolment | 07/02/2011 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Denmark Hill
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
Kings College London
University/education
University/education
Strand
London
WC2R 2LS
England
United Kingdom
| Website | http://www.kcl.ac.uk/index.aspx |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
British Renal Society
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BRS
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
Editorial Notes
18/12/2015: Publication reference added.
