Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0188124835
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of postoperative saline douching following endoscopic sinus 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
Condition
Surgery: Endoscopic sinus surgery (ESS)
Intervention
Randomised Controlled Study
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2003
Overall trial end date
01/02/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40 patients
Participant 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.
Recruitment start date
01/04/2003
Recruitment end date
01/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Otolaryngology
Chorley
PR7 1PP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Lancashire Teaching 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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18983380
Publication citations
-
Results
Freeman SR, Sivayoham ES, Jepson K, de Carpentier J, A preliminary randomised controlled trial evaluating the efficacy of saline douching following endoscopic sinus surgery., Clin Otolaryngol, 2008, 33, 5, 462-465, doi: 10.1111/j.1749-4486.2008.01806.x.