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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
855/UN2.F1/Etik/2014
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
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 study start date
01/04/2015
Overall study end date
31/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing laparoscopic living donor nephrectomy
Participant type(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 07/07/2016 | 02/04/2019 | No | No |
Additional files
- ISRCTN17143053_BasicResults_07Jul16.pdf Uploaded 02/04/2019