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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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29 April 2019 |
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Main ID: |
ISRCTN17143053 |
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Date of registration:
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20/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single-dose prophylaxis antibiotic in laparoscopic living donor nephrectomy
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Scientific title:
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Single dose prophylaxis antibiotic in laparoscopic living donor nephrectomy: a double-blind randomized controlled trial study |
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Date of first enrolment:
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01/04/2015 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN17143053 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Andry
Giovanny |
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Address:
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Jl. Diponegoro No 71
115320
Jakarta
Indonesia |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients undergoing laparoscopic living donor nephrectomy
Exclusion criteria: Having infection
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney transplantation
Surgery
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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).
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Secondary ID(s)
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855/UN2.F1/Etik/2014
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Source(s) of Monetary Support
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Cipto Mangunkusumo Hospital (Indonesia)
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Ethics review
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Status:
Approval date:
Contact:
855/UN2.F1/Etik/2014
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2015 |
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URL:
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