The effect of post-operative nasal packing on mucociliary activity
| ISRCTN | ISRCTN27163398 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27163398 |
| Secondary identifying numbers | N0025107235 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 31/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Tristram Hugh John Lesser
Scientific
Scientific
Otolaryngology
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
Study information
| Study design | Prospective randomised controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effect of post-operative nasal packing on mucociliary activity |
| Study objectives | We expect that nasal packs disrupt the nasal mucosal membrane for up to 3 months causing increased morbidity. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ear, Nose and Throat: Post-operative nasal packing |
| Intervention | Patients will be randomised to receive either Merocel, Vasolene gauze or no packs. The effect on the mucociliary transport will be assessed by performing a saccharin clearance test pre-operatively, after removal of packs prior to discharge and at subsequent clinic follow-up. It is envisaged that the packs will significantly alter the mucociliary transport time, leading to increased post-operative morbidity. This will lead to an alteration in departmental policy and fewer patients will be packed as a result. Data analysis of the results to assess the mucociliary transport rates will be done. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2001 |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 ENT patients |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Aintree Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
31/03/2020: No publications found, all search options exhausted, study status unverified.
