Recognition and expertise in the prevention of anal incontinence from ruptured sphincter
ISRCTN | ISRCTN61444699 |
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DOI | https://doi.org/10.1186/ISRCTN61444699 |
Secondary identifying numbers | N0158108052 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 10/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Khaled M K Ismail
Scientific
Scientific
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
Phone | +44 (0)121 627 2775 |
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kmkismail@aol.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | The REPAIR study - Recognition and Expertise in the Prevention of Anal Incontinence from Ruptured Sphincter: a randomised controlled trial |
Study acronym | REPAIR |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Anal incontinence at 1 year after repair |
Secondary outcome measures | Quality of life 1 year after repair |
Overall study start date | 01/10/2002 |
Completion date | 31/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | All |
Sex | Female |
Target number of participants | Not provided at time of registration (recruitment completed) |
Key inclusion criteria | 1. All women with complete obstetric anal sphincter rupture (3rd or 4th degree perineal tear) 2. Informed consent is given 3. Authorised clinician available to perform or supervise the repair |
Key exclusion criteria | 1. Previous surgery for obstetric repair or anal fistula 2. Refuse or withdraw consent |
Date of first enrolment | 01/10/2002 |
Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TG
United Kingdom
B15 2TG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Charity
North Staffordshire Medical Institute
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.