Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/02/2010
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

Dr Steve McDonald

ORCID ID

Contact details

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
stevemcdonald001@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0203157782

Study information

Scientific title

Acronym

Study hypothesis

In patients who have nasal surgery requiring nasal packing, which nose pack is the least uncomfortable to have removed: Netcell or Rapid-Rhino?

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: Nasal

Intervention

Patients meeting the inclusion criteria will be recruited into a randomised controlled trial, in which one nasal cavity is packed with Netcel, and the other with Rapid-Rhino.


Patients deemed suitable will be approached for their consent to participate in the trial. A record of all such patients will be kept, along with reasons for the decline to take part if this occurs, in line with the CONSORT recommendations. All patient-sensitive data stored will be anonymous.

Randomisation
This will occur at the end of the procedure, when the surgeon decides to definitely pack both sides of the nose. If this is desired, the pack chosen for the left nostril would be selected by telephone randomisation. The pack chosen for the right nostril would be, by default, the other type of pack.

Removal of packs
As per current departmental practice, the packs will be removed by the nursing staff at 7am the following morning. Five minutes prior to removal, and immediately following removal, patients will record their pain scores on a standard 10cm visual analogue scale (an unmarked line), with the 2 ends to signify no pain and the most severe pain imaginable. Patients will mark the same line for both the left and right sides of the nose, and label each mark accordingly. The scales for the pre- and post- removal scores will be on opposite sides of a piece of paper to avoid the scores influencing one another. The left pack will always be removed first. It is possible that the order in which the packs are removed could influence the level of pain felt when the two sides are compared. Always removing the left pack first will ensure that this source of bias is eliminated.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Difference in mean Visual analogue score (VAS) on removal of pack

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/02/2005

Overall trial end date

02/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients having septal surgery and trimming of inferior turbinates will be identified when they attend for pre-assessment clinic. They will be given the information about the trial at that point and given time to consider if they wish to take part before signing the consent form. Inclusion criteria will include:
1. Patients aged 16-65. Children and older adults excluded as pain responses are known to differ at extremes of age.
2. Patients undergoing septal surgery with bilateral inferior turbinate surgery. All consultants in the department routinely pack following this procedure, whereas preferences differ for other nasal operations.
This limited inclusion criterion also ensures that the same operation is carried out on each side of the nose.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

45

Participant exclusion criteria

1. Revision surgery
2. History of a bleeding tendency
3. Patients on anticoagulants or anti-platelet drugs
4. History of sino-nasal trauma
5. Underlying systemic/sino-nasal disease such as Wegner's disease, sarcoidosis, fungal sinusitis

Recruitment start date

02/02/2005

Recruitment end date

02/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
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

Royal Devon & Exeter Healthcare 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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19382493

Publication citations

  1. Results

    McDonald SE, Slater J, Powell R, Khalil HS, Garth RJ, A randomised controlled trial comparing Rapid Rhino Mannheim and Netcell series 5000 packs following routine nasal surgery., Rhinology, 2009, 47, 1, 41-44.

Additional files

Editorial Notes