Condition category
Urological and Genital Diseases
Date applied
08/01/2015
Date assigned
09/01/2015
Last edited
13/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bynvant Sandhu

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2012-000942-36

ClinicalTrials.gov number

Protocol/serial number

13238

Study information

Scientific title

Are prophylactic antibiotics necessary before laparoscopic living kidney donation? A double blind, randomised, controlled trial.

Acronym

PoWAR

Study hypothesis

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

12/LO/0877

Study design

Randomised; Interventional;

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2013

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 284; UK Sample Size: 284

Participant 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 breast-feeding women

Recruitment start date

01/01/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Guy's and St. Thomas' NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes