Efficacy of saline douching following endoscopic sinus surgery (ESS)
| ISRCTN | ISRCTN71717516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71717516 |
| Secondary identifying numbers | N0188124835 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 13/05/2009
- 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 S Freeman
Scientific
Scientific
Otolaryngology
Lancashire Teaching Hospitals NHS Trust LTHTR
Chorley
PR7 1PP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the effect of postoperative saline douching following endoscopic sinus surgery |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Endoscopic sinus surgery (ESS) |
| Intervention | Randomised Controlled Study |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Reduction of complications following operation and improvement in sinonasal symptoms at 3 weeks and then at 3 months. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2003 |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 patients |
| Key inclusion criteria | 1. Aged 18 or over 2. Diagnosis of acute or chronic rhinosinusitis or nasal polyposis 3. Patient listed for bilateral endoscopic sinus surgery |
| Key exclusion criteria | Other nasal surgery performed concomitantly, diagnosed with inflammatory or neoplastic nasal pathology, diagnosed with systemic conditions affecting the nose, gross difference in contralateral sinonasal disease as assessed radiologically and operatively, unilateral trimming of middle turbinate during ESS, patients listed for revision surgery, neoplasms-untreated or under active or recent tx with chemotherapy or radiotherapy, major psychiatric illness active or untreated with previous hospitalisation. |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Otolaryngology
Chorley
PR7 1PP
United Kingdom
PR7 1PP
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Lancashire Teaching 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No |
