Condition category
Surgery
Date applied
15/05/2016
Date assigned
20/12/2016
Last edited
20/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In a laparoscopic living donor nephrectomy (LLDN), a kidney is transplanted from a living donor to a patient. Antibiotics are often given to patients undergoing surgery to prevent infection (prophylactic antibiotics). The inappropriate use of antibiotics increases the risk of antibiotic resistance, so prophylactic antibiotics should be used for the shortest possible period. The aim of this study is to compare the effectiveness and safety of a single dose of antibiotics and 3 days of antibiotics in patients undergoing LLDN.

Who can participate?
Patients undergoing laparoscopic living donor nephrectomy

What does the study involve?
Participants are randomly allocated to one of two groups. The single dose group are given one dose of antibiotics before undergoing surgery. The 3 days group are given antibiotics before undergoing surgery and after the surgery continue to receive antibiotics twice daily for three days. The incidence of infection after the operation is compared between the two groups.

What are the possible benefits and risks of participating?
The results of this study could improve the way we use prophylactic antibiotics. There are minimal additional risks compared with standard LLDN.

Where is the study run from?
Cipto Mangunkusumo Hospital (Indonesia)

When is the study starting and how long is it expected to run for?
April 2015 to August 2015

Who is funding the study?
Cipto Mangunkusumo Hospital (Indonesia)

Who is the main contact?
Dr Andry Giovanny

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andry Giovanny

ORCID ID

Contact details

Jl. Diponegoro No 71
Jakarta
115320
Indonesia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

855/UN2.F1/Etik/2014

Study information

Scientific title

Single dose prophylaxis antibiotic in laparoscopic living donor nephrectomy: a double-blind randomized controlled trial study

Acronym

Study hypothesis

Proper antibiotic use is a concern due to the increase of antibiotic resistance. Standardized techniques and prophylactic antibiotics are widely used in urologic surgeries, but the prolonged administration of antibiotic after an operation has not been fully studied, especially clean contaminated surgery such as laparoscopy living donor nephrectomy (LLDN). This study aimed to evaluate the efficacy and safety of single-dose prophylactic antibiotic in laparoscopic live donor nephrectomy operation in Cipto Mangunkusumo Hospital, Jakarta.

Ethics approval

855/UN2.F1/Etik/2014

Study design

Randomized controlled trial

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

Kidney transplantation

Intervention

The patients were randomly divided into two groups. The single dose group were given 1 g cefoperazone as prophylactic antibiotics intravenously 30 minutes before surgery and after that water for injection was injected as a placebo twice daily for 3 days. The 3 days group were also given cefoperazone before surgery and continued twice daily for three days. When the duration of surgery exceeded 3 hours, we administered another extra 1 g of cefoperazone, considered as prophylactic. The incidence of post-operative infection and contributing factors were compared between the two groups. Physical examination was carried out daily during hospitalization, and on the 10th day after surgery at the scheduled follow-up consultation.

Intervention type

Drug

Phase

Not Applicable

Drug names

Cefoperazone

Primary outcome measure

Local infection at the 1st and 10th days after surgery. Local signs of infection include one of the following criteria: purulent discharge from the wound, tenderness/swelling/erythema, positive culture from a specimen taken from the wound with proper technique.

Secondary outcome measures

Systemic infection at the 1st and 10th days after surgery. The systemic signs of infection must meet both criteria: tachycardia (>100 beats/minutes) with temperature > 3oC and leukocytosis (>10.000 /mL).

Overall trial start date

01/04/2015

Overall trial end date

31/08/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients undergoing laparoscopic living donor nephrectomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

Having infection

Recruitment start date

01/04/2015

Recruitment end date

01/07/2015

Locations

Countries of recruitment

Indonesia

Trial participating centre

Cipto Mangunkusumo Hospital
Department of Urology University of Indonesia DIponegoro st. No 71
Daerah Khusus Ibukota Jakarta
15320
Indonesia

Sponsor information

Organisation

Cipto Mangunkusumo Hospital (Indonesia)

Sponsor details

Jl. Diponegoro No. 1
Jakarta
15320
Indonesia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Cipto Mangunkusumo Hospital (Indonesia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes