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
Protocol serial number	10025
Sponsor	Kings College London
Funder	British Renal Society

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

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised, interventional, treatment
Secondary study design	Non randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Orlistat
Primary outcome measure(s)	1. BMI <35 kg/m2 2. Measured at timepoint(s) of 6 and 12 months
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Denmark Hill

London
SE5 9RS
United Kingdom

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	01/01/2012		Yes	No

Editorial Notes

18/12/2015: Publication reference added.