A randomised trial of Bascom's procedure versus cleft closure for the management of primary pilonidal sinus disease
| ISRCTN | ISRCTN44896217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44896217 |
| Secondary identifying numbers | N0213108766 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr Neal Cripps
Scientific
Scientific
Directorate of Surgery
St Richard's Hospital
Spitalfield Lane
Chichester
PO19 4SE
United Kingdom
| neil.cripps@rws-tr.nhs.uk |
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 hypothesis | To test the hypothesis that Bascom's procedure for pilonidal sinus is as successful as cleft closure with respect to postoperative complications, time to complete healing and long-term recurrence rate. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Ear, Nose and Throat: Pilonidal sinus disease |
| Intervention | Randomised to treatment by Bascom's procedure or cleft closure. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2001 |
| Overall study end date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Added 05/05/10: 55 |
| Participant inclusion criteria | 1. Age over 16 2. Chronic pilonidal sinus disease that consultant considers to be suitable for Bascom's procedure 3. Patient willing to attend long-term follow-up |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/09/2001 |
| Recruitment end date | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Directorate of Surgery
Chichester
PO19 4SE
United Kingdom
PO19 4SE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Royal West Sussex Trust (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 | 01/02/2009 | Yes | No |
