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.: PACTR201306000556261 Date of Approval: 04/06/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title An RCT of early discharge with a catheter Vs late discharge after catheter removal following urogenital fistula repair among women in Mulago Hospital,
Official scientific title An RCT of early discharge with a catheter Vs late discharge after catheter removal following urogenital fistula repair among women in Mulago Hospital
Brief summary describing the background and objectives of the trial Uganda has a fistula prevalence of 2% (UDHS 2011).There is a small number of surgeons and few beds dedicated to fistula care, a condition resulting from neglected obstructed labor in more than 90 percent.With the existing backlog, the standard 14 days of stay on hospital beds following repair is a hindrance to accessing surgery by most of these women with fistula.his study aims at shortening the hospital based care by discharging fistula patients early (3-5 days)following surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UFEALD study
Disease(s) or condition(s) being studied Female urogenital Fistula,Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/01/2013
Actual trial start date 24/04/2013
Anticipated date of last follow up 31/01/2015
Actual Last follow-up date 26/04/2015
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
None N/A
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 Permuted block randomisation, equal block size of 6 computer generated by independent statistician and sealed in opaque envelopes Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early discharge with catheter following urogenital fistula repair discharged 3-5 days 12 weeks stable patients whose fistula lie more than 1cm from External urethra orifice are discharged with catheter and reviewd 14 days, 6 weeks and 12 weeks and outcomes measured on the three follow up days 150
Control Group Late (standard) discharge after catheter removal following urogenital fistula repair 14 days 12 weeks stable patients whose fistula lie more than 1cm from External urethra orifice will be followed up as per current practiceare and will be discharged after catheter removal on 14 postoperative day and review at 6 weeks and 12 weeks and outcomes measured on the three follow up days 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women with urogenital fistula, following surgery irrespective of route, fistula 1cm or more from external urethra orifice, surgeon has confirmed closure by negative dye test, fistula still closed by day 3-5, if consented and stable will be randomized and included in the study women with both urogenital and recto-vaginal fistula, extensive fibrosis, fistula within 1cm from external urethra orifice, bladder length of less than 5cm (small capacity bladder), leakage after repair up to 3 days, fistula following malignancy, fistulas following infection, very sick patient after surgery or during surgery, those with overt infection women who come from far (transport cost more than 40,000 Uganda shillings 13 Year(s) 80 Year(s) Female
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 14/02/2013 Makerere Universirty, College of Health Sciences, School of Medicine research and ethics committee
Ethics Committee Address
Street address City Postal code Country
Mulago Hospital Kampala +256 Uganda
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 04/04/2013 Uganda national council of science and technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, KImera road , Ntinda Kampala +256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome fistula closure rates 2 weeks, 6weeks and 12 weeks
Secondary Outcome rates of complications: catheter blockage, post repair urethral incontinence, infections leading to readmission, acceptabilty of catheter, quality of life change in relationshipships following treatment among the 2 groups 2 weeks, 6 weeks and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago Hospital Mulago Hill Road, Wandegeya, box 7051 Kampala +256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Makerere- Karolinska collaboration sponsored by sida Solna Stockholm +46 Sweden
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere- Karolinska collaboration sponsored by sida Stockholm - headquarters Valhallavägen 199 105 25 Stockholm Stockholm +49 Sweden University
COLLABORATORS
Name Street address City Postal code Country
Karolinska Institutet Widerströmska building, 4th floor, Tomtebodavägen 18A, Solna, SE-171 77 STOCKHOLM Stockholm +46 Sweden
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justus Kafunjo Barageine barageinej@gmail.com +256712454869 Mulago Hill road, Wandegeya, Box 7051, Kampala
City Postal code Country Position/Affiliation
Kampala +256 Uganda PhD Student, Hon lecturer, fistula surgeon
Role Name Email Phone Street address
Public Enquiries Josaphat K Byamugisha byamugisha2001@yahoo.com +256772580330 Mulago Hill road, Wandegeya, Box 7051, Kampala
City Postal code Country Position/Affiliation
Kampala +256 Uganda Head of Department of Obstetrics and Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Elisabeth Faxelid Elisabeth.Faxelid@ki.se + 46 8 52483351 Widerströmska building, 4th floor, Tomtebodavägen 18A, Karolinska Institutet, Solna, SE-171 77 STOCKHOLM
City Postal code Country Position/Affiliation
Stockholm +46 Sweden Professor of reproductive health
REPORTING
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