Randomised Controlled Trial (RCT) comparing two methods of repairing external anal sphincter lacerations
| ISRCTN | ISRCTN04149919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04149919 |
| Secondary identifying numbers | MCT-41547 |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 10/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Scott Alexander Farrell
Scientific
Scientific
IWK Health Center
5980 University Ave.
Room 6039
Halifax, Nova Scotia
B3J 3G9
Canada
| Phone | +1 902 470 6768 |
|---|---|
| scott.farrell@iwk.nshealth.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from IWK Health Centre Research Ethics Board on the 15th April 2005. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2000 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Complete third or fourth degree tear of the External Anal Sphincter 2. Aged 18 - 49 years old, female |
| Key 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 |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- Canada
Study participating centre
IWK Health Center
Halifax, Nova Scotia
B3J 3G9
Canada
B3J 3G9
Canada
Sponsor information
Dalhousie University (Nova Scotia) (Canada)
University/education
University/education
1236 Henry Street
Halifax, Nova Scotia
B3H 3J5
Canada
| Website | http://www.dal.ca/ |
|---|---|
"ROR" |
https://ror.org/01e6qks80 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-41547)
No information available
Nova Scotia Health Research Foundation (Canada)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- NSHRF
- Location
- Canada
Dalhousie Medical Research Foundation (Canada)
No information available
The Atlee Foundation (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2010 | Yes | No | |
| Results article | results | 01/10/2012 | Yes | No |
