A randomised trial of antibiotics in laparoscopic donor nephrectomy

ISRCTN	ISRCTN71141360
DOI	https://doi.org/10.1186/ISRCTN71141360
EudraCT/CTIS number	2012-000942-36
ClinicalTrials.gov number	NCT02089568
Secondary identifying numbers	13238

Submission date: 08/01/2015
Registration date: 09/01/2015
Last edited: 28/05/2020

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

Plain English summary under review

Contact information

Dr Bynvant Sandhu
Scientific

Renal Unit
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Study information

Study design	Randomised; Interventional;
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Are prophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial
Study acronym	PoWAR
Study objectives	Around two-thirds of all kidney transplants in the UK are performed using kidneys from living kidney donors; these are indviduals who have volunteered to donate one of their kidneys. Every attempt is made to minimise the risk of complications in these patients, who do not have any need to undergo surgery. We know that a significant number (10-15%) of these patients will have infections (such as infections of their surgical wound, urinary infections or chest infections) after surgery. These infections may lead to a longer time spent in hospital, re-attendance at the hospital, GP or local Emergency department after discharge and a longer recovery time. Most donors are working and a delay in returning to work is important to them. Infections may cause significant discomfort and anxiety. Costs are increased (threefold) due to the longer hospital stay. A single dose of antibiotics given at the start of surgery is often used to prevent surgical site infections. However, whether this is beneficial for living donors has not been tested. Patients undergoing bowel surgery for example, are usually ill (donors are healthy) and bowel surgery is regarded as a 'contaminated' operation, due to the bacteria within the gut. Living kidney donation however may not involve potential contamination with bacteria. If antibiotics are used unnecessarily, consequences include side effects, such as diarrhoea and allergic reactions (which can be serious), the spread of resistance to antibiotics, and an extra cost. We are therefore proposing a trial which will compare the risk of infections, side effects, hospital stay and costs in those who receive a dose of antibiotics and those who receive a placebo (which would be an injection of salt water). The patients will be randomised by a computer to one or other treatment, and patients will be followed for one month after surgery. We expect that the findings will be easy to implement across the UK for living donors.
Ethics approval(s)	12/LO/0877
Health condition(s) or problem(s) studied	Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders
Intervention	A single intravenous dose (1.2g) of the IMP (or placebo) will be given at induction of anaesthesia.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	The primary outcome measure will be a composite endpoint of any infection; this will include surgical site infections as well as urinary tract, respiratory and any other infections, within 30 days of surgery.
Secondary outcome measures	1. Ultrasonic evidence of wound healing 2. Length of hospital stay 3. Readmission rates 4. Antibiotic associated side effects (including diarrhoea and allergic reactions), return to work and normal activities 5. Quality of life and relative costs
Overall study start date	01/01/2013
Completion date	30/04/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 284; UK Sample Size: 284
Total final enrolment	295
Key inclusion criteria	1. All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included 2. Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice 3. Women of child-bearing age taking adequate contraception will be included
Key exclusion criteria	1. Patients with a known allergy to penicillin or other antibiotics 2. Patients with MRSA colonisation 3. Participation in another investigational study within the previous 90 days 4. Pregnant or breastfeeding women
Date of first enrolment	01/01/2013
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Renal Unit

Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor information

Guy's and St. Thomas' NHS Foundation Trust
Hospital/treatment centre

Research & Development Dept 2nd Floor Conybeare House
Great Maze Pond
London
SE1 9RT
England
United Kingdom

"ROR"	https://ror.org/00j161312

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
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?
Basic results			28/05/2020	No	No
HRA research summary			28/06/2023	No	No

Editorial Notes

28/05/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
23/07/2019: ClinicalTrials.gov number added. No publications found in PubMed, verifying study status with principal investigator.
16/05/2018: No publications found, verifying study status with principal investigator.