Recognition and expertise in the prevention of anal incontinence from ruptured sphincter

ISRCTN	ISRCTN61444699
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

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
Email	kmkismail@aol.com

Study information

Study design	Randomised controlled trial
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
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

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Charity

North Staffordshire Medical Institute

No information available

Results and Publications

Intention to publish date
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.