Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0300148808
Study information
Scientific title
Acronym
Study hypothesis
Does medialising the middle turbinate with a single transfixion suture after functional endoscopic sinus surgery FESS improve the outcome of surgery?
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Nose
Intervention
1. Medialisation of Middle Turbinate with transfixion suture performed
2. Suture not performed
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Pain, nasal obstruction, sense of smell, ante/post rhinorrhoea.
Secondary outcome measures
Size of access of middle meatus, presence/absence of adhesions.
Overall trial start date
01/10/2003
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing anterior/ posterior ethmiodal FESS +/- Septoplasty.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients in whom middle turbinate has been trimmed, previous septal or middle turbinate surgery.
Recruitment start date
01/10/2003
Recruitment end date
01/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
East Lancashire Hospitals NHS Trust
Blackburn
BB2 3HH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Lancashire Hospitals NHS Trust (UK)
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
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16008072
Publication citations
-
Results
Bhalla RK, Kaushik V, de Carpentier J, Conchopexy suture to prevent middle turbinate lateralisation and septal haematoma after endoscopic sinus surgery., Rhinology, 2005, 43, 2, 143-145.