Contact information
Type
Scientific
Primary contact
Dr Khaled M K Ismail
ORCID ID
Contact details
Professor of Obstetrics and Gynaecology
School of Clinical & Experimental Medicine
College of Medical & Dental Sciences
University of Birmingham
3rd Floor
Birmingham Women's Foundation Trust
Edgbaston
Birmingham
B15 2TG
United Kingdom
+44 (0)121 627 2775
kmkismail@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0158108052
Study information
Scientific title
The REPAIR Study - Recognition and Expertise in the Prevention of Anal Incontinence from Ruptured Sphincter
Acronym
Study hypothesis
Which method of surgical repair for 3rd and 4th degree obstetric anal sphincter injury results in the better outcome (the overlap method or the juxtaposition method), in terms of the incidence of anal incontinence at 12 months postpartum?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urological and Genital Diseases: Anal incontinence
Intervention
The proposed trial is a conventional randomised controlled trial of surgical method in the management of an infrequent complication of childbirth that nevertheless blights the lives of many thousands of women in the UK, and more worldwide. The team also hope to be able to draw conclusions about the impact on outcome that arises from the individual skill of the clinician undertaking the repair.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Anal incontinence at 1 year after repair.
Secondary outcome measures
Quality of life 1 year after repair.
Overall trial start date
01/10/2002
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
All women with complete obstetric anal sphincter rupture (3rd or 4th degree perineal tear) where informed consent is given and an authorised clinician is available to perform or supervise the repair. Women who have had previous surgery for obstetric repair or anal fistula will be excluded, as will those who refuse or withdraw their consent.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration (recruitment completed)
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2002
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
North Staffordshire Medical Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary