Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/05/2009
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 S Freeman

ORCID ID

Contact details

Otolaryngology
Lancashire Teaching Hospitals NHS Trust LTHTR
Chorley
PR7 1PP
United Kingdom

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 (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

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

  1. 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.

Additional files

Editorial Notes