|
ISRCTN
|
ISRCTN61444699
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The REPAIR Study - Recognition and Expertise in the Prevention of Anal Incontinence from Ruptured Sphincter
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0158108052
|
|
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?
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Urological and Genital Diseases: Anal incontinence
|
|
Participants - 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.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/10/2002
|
|
Anticipated end date
|
31/12/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
Not provided at time of registration (Recruitment completed)
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Anal incontinence at 1 year after repair.
|
|
Secondary outcome measure(s)
|
Quality of life 1 year after repair.
|
|
Sources of funding
|
North Staffordshire Medical Institute
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Khaled
M K Ismail
|
|
Address
|
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
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B15 2TG
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)121 627 2775
|
|
Fax
|
+44 (0)121 623 6875
|
|
Email
|
kmkismail@aol.com
|
|
Sponsor
|
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)207 307 2622
|
|
Fax
|
+44 (0)207 307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
12/09/2003
|
|
Last edited
|
17/01/2012
|
|
Date ISRCTN assigned
|
12/09/2003
|
