Randomised controlled trial of reconstruction against secondary intention healing of defects of the medial canthus
| ISRCTN | ISRCTN65017165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65017165 |
| Secondary identifying numbers | N0192080944 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 01/09/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr AJE Foss
Scientific
Scientific
Department of Ophthalmology
B Floor, South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 9249924 (44249) |
|---|---|
| alexander.foss@nuh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial of reconstruction against secondary intention healing of defects of the medial canthus |
| Study hypothesis | How do the results of formal reconstruction of defects of the medial canthus compare against healing by secondary intention, following tumour excision? 01/09/2015: Trial was abondoned in 1999 due to an inability to recruit participants as all patients wanted to be in the intervention group. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Surgery: Reconstruction of medial canthus |
| Intervention | Randomised controlled trial. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Snelen visual acuity, diplopia, patency of lacrimal system, lid mal-positions, features of corneal exposure, photographs with four expressions, quality of life assessment. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 17/02/1999 |
| Overall study end date | 31/12/1999 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 50 |
| Participant inclusion criteria | 60>, Caucasian, less than 1/3 of either upper or lower lid being involved, dimension of defect must measure less than 4x4 cm, the centre of the defect must be within 1.5 cm of the medial canthal tendon. |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 17/02/1999 |
| Recruitment end date | 31/12/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Ophthalmology
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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
Hospital/treatment centre
Nottingham University Hospitals NHS 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 |
