Recognition and expertise in the prevention of anal incontinence from ruptured sphincter
| ISRCTN | ISRCTN61444699 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61444699 |
| Protocol serial number | N0158108052 |
| Sponsor | Department of Health (UK) |
| Funder | North Staffordshire Medical Institute |
- 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 |
|---|---|
| kmkismail@aol.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Anal incontinence at 1 year after repair |
| Key secondary outcome measure(s) |
Quality of life 1 year after repair |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
University of Birmingham
Birmingham
B15 2TG
United Kingdom
B15 2TG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.
