Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/04/2012
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

Mr T H Malik

ORCID ID

Contact details

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

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

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

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

  1. 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.

Additional files

Editorial Notes