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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906496802845 Date of Registration: 03/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title OUTCOMES OF END TO END VERSUS OVERLAPPING TECHNIQUES OF REPAIR OF CHRONIC OBSTETRIC ANAL SPHINCTER INJURY, A RANDOMISED CONTROLLED TRIAL
Official scientific title OUTCOMES OF END TO END VERSUS OVERLAPPING TECHNIQUES OF REPAIR OF CHRONIC OBSTETRIC ANAL SPHINCTER INJURY, A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial BACKGOUND During delivery some women sustain 3rd and 4th degree tears that are not repaired immediately after delivery. These women suffer with faecal and flatus incontinence, perineal pain and dyspareunia. There are two known techniques of repair of these tears, end to end and overlapping technique. Trials have been done to discover which technique to superior to the other but none of these trials have been done in Sub Saharan Africa and none has been done for repair of chronic tears. OBJECTIVES General objective To compare the outcomes of end to end versus overlapping techniques of repair of chronic 3rd and 4th degree perineal tears in Mulago National Referral Hospital . Specific Objectives i. To compare the proportion of patients with flatal-faecal incontinence 3 months post operatively following repair of chronic third and fourth degree perineal tears with end to end versus overlapping techniques of repair in Mulago National Referral Hospital. ii. To compare the proportion of patients with complications; wound breakdown and perineal pain 3 months post operatively following repair of chronic third and fourth degree perineal tears with end to end or overlapping techniques of repair in Mulago National Referral Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Obstetric Anal Sphincter Injury
Purpose of the trial Treatment: Surgery
Anticipated trial start date 11/02/2019
Actual trial start date 22/02/2019
Anticipated date of last follow up 13/09/2019
Actual Last follow-up date 13/09/2019
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Overlapping technique 1 hour Repair of the torn ends of the external anal sphincter with overlapping technique 52
Control Group End to End technique 1 hour Repair of the torn ends of the external anal sphincter with end to end technique 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women with chronic Obstetric anal sphincter injury for at least 6 weeks and are ready for secondary closure. Women who are unable to provide informed consent to participate in the study. Pregnant women will be excluded from the study. Women with genital fistula and genital prolapse will be excluded from the study. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 04/02/2019 Makerere University Chool of Medicine Reseach and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
kampala kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Flatal-faecal incontinence that will be measured with an interviewer administered questionnaire. 12 WEEKS
Secondary Outcome The secondary outcomes include; perineal pain and wound breakdown that will be assessed with an interviewer administered questionnaire. 12 WEEKS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MULAGO NATIONAL REFERRAL HOSPITAL MULAGO HILL KAMPALA 7051 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Tino Kevin Okedi Luzira Kampala 9592 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TINO KEVIN OKEDI KAMPALA KAMPALA 9592 Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator TINO KEVIN OKEDI tinookedi@yahoo.com +256782694038 Kampala
City Postal code Country Position/Affiliation
Kampala 9592 Uganda Student of Masters in Medicine Obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Ocama Ponsiano ponsiano.ocama@gmail.com +256772421190 KAMPALA
City Postal code Country Position/Affiliation
KAMPALA 7072 Uganda PROFESSOR MAKERERE UNIVERSITY
Role Name Email Phone Street address
Scientific Enquiries Barageine Justus Kafunjo barageinej@gmail.com +256702454869 KAMPALA
City Postal code Country Position/Affiliation
KAMPALA 7072 Uganda Lecturer Makerere University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The particulars to be shared include the patients obstetric history, socioeconomic status, marital history and biodata Study Protocol With in 12 months of completion of the trial Controlled access to the data Data analysis will be multivariate The request for data will be through the principal investigators email Permission will be granted by the principal investigator Criteria for reviewing requests will be based on the qualifications of the person requesting
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No website available 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