A randomised trial of antibiotics in laparoscopic donor nephrectomy.v1

• Research type

  Research Study

• Full title

  A randomised trial of antibiotics in laparoscopic donor nephrectomy

• IRAS ID

  102270

• Contact name

  Nizam Mamode

• Sponsor organisation

  Guy's & St Thomas' NHS Foundation Trust

• Eudract number

  2012-000942-36

• ISRCTN Number

  n/a

• Research summary

  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.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/0877

• Date of REC Opinion

  4 Oct 2012

• REC opinion

  Further Information Favourable Opinion