Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Valerie J Lund

ORCID ID

Contact details

Department of ENT
RNTNE
Royal Free Hampstead NHS Trust
330 Grays Inn Road
King's Cross
London
WC1X 8DA
United Kingdom
+44 (0)20 7915 1300
v.lund@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256159712

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

mitomycin C

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2005

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of ENT, RNTNE
London
WC1X 8DA
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The Royal Free Hampstead NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Professorial Unit RNTNE

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results of pilot study on http://www.ncbi.nlm.nih.gov/pubmed/17181099

Publication citations

  1. Results of pilot study

    Amonoo-Kuofi K, Lund VJ, Andrews P, Howard DJ, The role of mitomycin C in surgery of the frontonasal recess: a prospective open pilot study., Am J Rhinol, 20, 6, 591-594.

Additional files

Editorial Notes