Single-dose prophylaxis antibiotic in laparoscopic living donor nephrectomy
| ISRCTN | ISRCTN17143053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17143053 |
| Secondary identifying numbers | 855/UN2.F1/Etik/2014 |
- Submission date
- 15/05/2016
- Registration date
- 20/12/2016
- Last edited
- 02/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Jl. Diponegoro No 71
Jakarta
115320
Indonesia
Study information
| Study design | Randomized controlled trial |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | Single dose prophylaxis antibiotic in laparoscopic living donor nephrectomy: a double-blind randomized controlled trial study |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | Patients undergoing laparoscopic living donor nephrectomy |
| Key exclusion criteria | Having infection |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 01/07/2015 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
University of Indonesia
DIponegoro st. No 71
Daerah Khusus Ibukota Jakarta
15320
Indonesia
Sponsor information
Hospital/treatment centre
Jl. Diponegoro No. 1
Jakarta
15320
Indonesia
"ROR" |
https://ror.org/05am7x020 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 | 07/07/2016 | 02/04/2019 | No | No |
Additional files
- ISRCTN17143053_BasicResults_07Jul16.pdf
- Uploaded 02/04/2019
Editorial Notes
02/04/2019: The basic results of this trial have been uploaded as an additional file.
