Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201808161376054 Date of Approval: 07/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Short term Versus Long term Antimicrobial Prophylaxis in preventing postoperative Infectious Complications among patients undergoing Transurethral Resection of Prostate at KCMC
Official scientific title Effect of Short term Versus Long term Antimicrobial Prophylaxis in preventing postoperative Infectious Complications among patients undergoing Transurethral Resection of Prostate at KCMC
Brief summary describing the background and objectives of the trial Transurethral resection of the prostate is a common procedure in Urology and the most common operation at Institute of Urology at KCMC (Mohee et al, 2016; KCMC theatre registry). Despite, the proven importance of antibiotics in preventing postoperative complications in patients undergoing Transurethral resection of the prostate (two systematic review: Berry et al, 2002; Qiang et al, 2005), overuse of antibiotics is associated with increase in drug resistance, morbidity and increase in health care costs (Kutlu et al,2012; Riedel et al,2007). More recent data suggest that short term antimicrobial prophylaxis is equally effective to long term antimicrobial prophylaxis in preventing postoperative urinary tract infection, and severe infectious complication such as urosepsis in low risk patients undergoing TURP (Grabe et al,2016; Basim et al,2013). However, most randomized clinical trials which proved the efficacy and effectiveness of short term antimicrobial prophylaxis excluded catheterized patients. In our setting, the majority of the patients present with a bladder outlet obstruction requiring catheterization. These patients have a higher risk of infectious complications and are presently managed by a long-term antimicrobial treatment. This study aims at evaluating the hypothesis that a short term antimicrobial course is equally effective (not inferior to) to that of a long term antimicrobial course in preventing post operative infectious complications in patients undergoing transurethral resection of prostate for bladder outlet obstruction treated by indwelling catheter Broad objective • To compare effectiveness of short-term versus long-term doses of perioperative antibiotics prophylaxis in preventing postoperative infections among patients undergoing TURP at KCMC. Specific objectives 1. To compare effectiveness of short-term versus long-term doses of perioperative antibiotic prophylaxis in preventing postoperative bacteriuria. 2. To compare effectiveness of short-term versus long-term doses of perioperative antibiotic prophylaxis in preventing postoperative symptomatic UTI . 3. To compare occurrance of fever in patients who received short-term versus long-term antibiotic prophylaxis. 4. To compare effectiveness of short-term versus long-term doses of perioperative antibiotic prophylaxis in preventing postoperative clinical sepsis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2017
Actual trial start date 03/09/2017
Anticipated date of last follow up 30/09/2018
Actual Last follow-up date 31/08/2018
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Duration of antibiotic course For control group: Intravenous gentamicin 160 mg once a day for 3 days and on discharge(2nd day post operative ) patients given Tablets ciproffoloxacin 500 mg bid for 5 days and tablets paracetamol for 3 days. First dose of gentamicin is given 30 minutes before surgery 8 days Intervention is giving Intravenous Gentamicin 160 mg once a day for three days and on discharge given paracetamol for 3 days. 44 Dose Comparison
Experimental Group duration of antibiotic course Intravenous gentamicin 160 mg once a day for 3 days and on discharge second day postoperative patient is given Tablets paracetamol 1 gm tid for 3 days. 3 days course of antibiotic The difference between intervention group and control group is dutration of antibiotic couse where in intervetion patients are given antibiotics after Transurethral resection of prostate for 3 days while in control group are given for 8 days. 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Catheterized patients 18 years or older with Bladder Outlet Obstruction secondary to an enlargement of the prostate with bladder outlet obstruction, admitted for Transurethral Resection of Prostate. • Patients with a urine culture and sensitivity testing showing no resistance to gentamicin and/or ciprofloxacin. • Who speak and understand Kiswahili • Who provide a written informed consent • Patients who will fail to void postoperative after removal of catheter (the number will be recorded) Patients with renal failure (serum creatinine above 200µmol/l) , uncontrolled DM and Immunocompromised • Patients with internal prosthesis. • Patients who received antibiotics within one week prior to surgery. • Patients who do not wish to participate. • Patients whose urine culture are resistant to gentamicin and/or ciprofloxacin( on long term arm ). 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/08/2017 Kilimanjaro Christian Medical College Research Ethics and and Review Comittee
Ethics Committee Address
Street address City Postal code Country
Loguo-KCMC, P.O Bo 2240, MOSHI,Tanzania. Moshi 0255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of asymptomatic bacteriuria as determined by mid stream urinalysis and urine culture and sensitivity Ninth to eleventh day post operative Transurethral resection of prostate
Secondary Outcome incidence of symptomatic urinary tract infections , fever and clinical sepsis. ninth to eleventh day post operative i.e. Transurethral resection of prostate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Centre. Longuo, KCMC P.O. Box 3010 , MOSHI,Tanzania Moshi 0255 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
THRIVE 2 MASTERS GRANT FOR RESIDENT AND MASTER STUDENTS AT Kilimanjaro Christian Medical University College Longuo -KCMC Moshi 0255 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor THRIVE 2 master grant Longuo-KCMC Moshi 0255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Orgeness Mbwambo orgeness@live.com +255713863733 Longuo A, Good Samaritan Foundation flats , house number 18A
City Postal code Country Position/Affiliation
Moshi 0255 Tanzania Third year resident in Urology
Role Name Email Phone Street address
Public Enquiries Frank Bright frankbright2001@gmail.com +255754543659 shunty town, Moshi
City Postal code Country Position/Affiliation
Moshi 0255 Tanzania Head of Urology department at Kilimanjaro Christian Medical Centre
Role Name Email Phone Street address
Scientific Enquiries Kien Mteta akamteta@gmail.com +255754305720 Kiboroloni-Moshi
City Postal code Country Position/Affiliation
Moshi 0255 Tanzania Deputy Provost for Academic Affairs at Kilimajaro Christian Medical University College
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information