Contact information
Type
Scientific
Primary contact
Dr Scott Alexander Farrell
ORCID ID
Contact details
IWK Health Center
5980 University Ave.
Room 6039
Halifax
Nova Scotia
B3J 3G9
Canada
+1 902 470 6768
scott.farrell@iwk.nshealth.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-41547
Study information
Scientific title
Acronym
Study hypothesis
When overlapping surgical repair of third and fourth degree obstetrical lacerations of the external anal sphincter is compared to the standard end-to-end method, it will result in superior symptomatic, anatomical and functional outcomes.
Ethics approval
Ethics approval received from IWK Health Centre Research Ethics Board on the 15th April 2005.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Third or Fourth degree tear of the External Anal Sphincter (EAS) at childbirth.
Intervention
Two arms:
1. Traditional end-to-end repair of the EAS
2. Overlapping repair of the EAS
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Rate of flatal incontinence at 6 months post repair.
Secondary outcome measures
1. Rate of fecal incontinence at 6 months post repair
2. Integrity of EAS by endoanal ultrasound
3. Function of EAS by anal manometry
4. Quality of life by validated QOL measure
5. Post-operative complications
Overall trial start date
01/10/2000
Overall trial end date
30/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Complete third or fourth degree tear of the External Anal Sphincter
2. Aged 18 - 49 years old, female
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150
Participant exclusion criteria
1. Previous 3rd or 4th degree tear
2. Significant history of anal incontinence
3. Inflammatory bowel disease or other gastrointestinal condition which might affect functional outcome
Recruitment start date
01/10/2000
Recruitment end date
30/09/2003
Locations
Countries of recruitment
Canada
Trial participating centre
IWK Health Center
Halifax, Nova Scotia
B3J 3G9
Canada
Sponsor information
Organisation
Dalhousie University (Nova Scotia) (Canada)
Sponsor details
1236 Henry Street
Halifax
Nova Scotia
B3H 3J5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41547)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nova Scotia Health Research Foundation (Canada)
Alternative name(s)
NSHRF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Canada
Funder name
Dalhousie Medical Research Foundation (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Atlee Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20567163
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22955309
Publication citations
-
Results
Farrell SA, Gilmour D, Turnbull GK, Schmidt MH, Baskett TF, Flowerdew G, Fanning CA, Overlapping compared with end-to-end repair of third- and fourth-degree obstetric anal sphincter tears: a randomized controlled trial., Obstet Gynecol, 2010, 116, 1, 16-24, doi: 10.1097/AOG.0b013e3181e366ef.
-
Results
Farrell SA, Flowerdew G, Gilmour D, Turnbull GK, Schmidt MH, Baskett TF, Fanning CA, Overlapping compared with end-to-end repair of complete third-degree or fourth-degree obstetric tears: three-year follow-up of a randomized controlled trial., Obstet Gynecol, 2012, 120, 4, 803-808, doi: 10.1097/AOG.0b013e31826ac4bb.