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 |
| Protocol serial number | N0300148808 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | East Lancashire Hospitals NHS Trust (UK) |
- 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
Scientific
East Lancashire Hospitals NHS Trust
The Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Does 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) studied | Surgery: Nose |
| Intervention | 1. Medialisation of Middle Turbinate with transfixion suture performed 2. Suture not performed |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Pain, nasal obstruction, sense of smell, ante/post rhinorrhoea. |
| Key secondary outcome measure(s) |
Size of access of middle meatus, presence/absence of adhesions. |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients undergoing anterior/ posterior ethmiodal FESS +/- Septoplasty. |
| Key exclusion criteria | Patients in whom middle turbinate has been trimmed, previous septal or middle turbinate surgery. |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
East Lancashire Hospitals NHS Trust
Blackburn
BB2 3HH
United Kingdom
BB2 3HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
