A prospective , double blind, randomised controlled trial evaluating the effects of mitomycin C on postoperative healing following endoscopic sinus surgery (ESS) to the frontonasal recess.
| ISRCTN | ISRCTN42522811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42522811 |
| Secondary identifying numbers | N0256159712 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 10/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Valerie J Lund
Scientific
Scientific
Department of ENT, RNTNE
Royal Free Hampstead NHS Trust
330 Grays Inn Road
King's Cross
London
WC1X 8DA
United Kingdom
| Phone | +44 (0)20 7915 1300 |
|---|---|
| v.lund@ucl.ac.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 |
| Scientific title | |
| Study objectives | The study aims to evaluate the effects of mitomycin C on wound healing, its effects in the prevention of the formation of adhesions as well as preventing restenosis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Endoscopic sinus surgery (ESS) |
| Intervention | Patients undergoing ESS to the frontonasal recess for chronic rhinosinusitis are randomly allocated to receive either MMC or placebo solution applied to the frontonasal recess. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | mitomycin C |
| Primary outcome measure | 1. Patency of the frontonasal recess. 2. Study of the formation of adhesions and rate of restenosis post operatively. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2005 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of ENT, RNTNE
London
WC1X 8DA
United Kingdom
WC1X 8DA
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Royal Free Hampstead NHS Trust (UK)
No information available
Professorial Unit RNTNE
No information available
NHS R&D Support Funding
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 of pilot study | 01/11/2006 | Yes | No |
