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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe REPAIR study - Recognition and Expertise in the Prevention of Anal Incontinence from Ruptured Sphincter: a randomised controlled trial
Study acronymREPAIR
Study objectivesWhich 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) studiedUrological and Genital Diseases: Anal incontinence
InterventionThe 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 typeProcedure/Surgery
Primary outcome measureAnal incontinence at 1 year after repair
Secondary outcome measuresQuality of life 1 year after repair
Overall study start date01/10/2002
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAll
SexFemale
Target number of participantsNot provided at time of registration (recruitment completed)
Key inclusion criteria1. 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 criteria1. Previous surgery for obstetric repair or anal fistula
2. Refuse or withdraw consent
Date of first enrolment01/10/2002
Date of final enrolment31/12/2008

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

10/07/2017: No publications found, verifying study status with principal investigator.