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
Protocol serial number	N0256159712
Sponsor	Department of Health
Funders	The Royal Free Hampstead NHS Trust (UK), Professorial Unit RNTNE, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Valerie J Lund
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
Email	v.lund@ucl.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	mitomycin C
Primary outcome measure(s)	1. Patency of the frontonasal recess. 2. Study of the formation of adhesions and rate of restenosis post operatively.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Department of ENT, RNTNE

London
WC1X 8DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results of pilot study	01/11/2006		Yes	No