Middle turbinate medialisation using a transfixion suture following functional endoscopic sinus surgery: how effective is it in maintaining patency of the middle meatus?

ISRCTN ISRCTN64097182
DOI https://doi.org/10.1186/ISRCTN64097182
Secondary identifying numbers N0300148808
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
24/04/2012
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

Mr T H Malik
Scientific

East Lancashire Hospitals NHS Trust
The Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesDoes medialising the middle turbinate with a single transfixion suture after functional endoscopic sinus surgery FESS improve the outcome of surgery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Nose
Intervention1. Medialisation of Middle Turbinate with transfixion suture performed
2. Suture not performed
Intervention typeProcedure/Surgery
Primary outcome measurePain, nasal obstruction, sense of smell, ante/post rhinorrhoea.
Secondary outcome measuresSize of access of middle meatus, presence/absence of adhesions.
Overall study start date01/10/2003
Completion date01/10/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients undergoing anterior/ posterior ethmiodal FESS +/- Septoplasty.
Key exclusion criteriaPatients in whom middle turbinate has been trimmed, previous septal or middle turbinate surgery.
Date of first enrolment01/10/2003
Date of final enrolment01/10/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

East Lancashire Hospitals NHS Trust
Blackburn
BB2 3HH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

East Lancashire Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2005 Yes No