Condition category
Respiratory
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/10/2012
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 Parmod K Jain

ORCID ID

Contact details

Associate ENT Specialist
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
+44 01202 448290
parmod.jain@poole.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0186191632

Study information

Scientific title

Acronym

Study hypothesis

To demonstrate the perceived advantage of guillotine tonsillectomy versus cold steel dissection tonsillectomy in children.

Ethics approval

Added August 2008: Poole Hospital NHS Foundation Trust local ethics approval LREC no. 06/Q2201/49, 30/05/2006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Tonsillectomy

Intervention

Guillotine versus cold dissection tonsillectomy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Compare the perceived advantages of guillotine tonsillectomy versus cold steel dissection in children.

Secondary outcome measures

1. Duration of procedure
2. Blood Loss
3. Methods required to arrest bleeding during the operation Pain scores after operation
4. Complication rates after the operation, in particular bleeding rates

Overall trial start date

08/03/2007

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 3 to 12 undergoing a tonsillectomy.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Previous quinsy
2. Bleeding clotting disorder
3. Concurrent adenoidectomy

Recruitment start date

08/03/2007

Recruitment end date

31/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Associate ENT Specialist
Poole
BH15 2JB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
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

Poole Hospital NHS Foundation Trust (UK) NHS R&D Support Funding

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22963759

Publication citations

  1. Results

    Frampton SJ, Ward MJ, Sunkaraneni VS, Ismail-Koch H, Sheppard ZA, Salib RJ, Jain PK, Guillotine versus dissection tonsillectomy: randomised, controlled trial., J Laryngol Otol, 2012, 126, 11, 1142-1149, doi: 10.1017/S002221511200196X.

Additional files

Editorial Notes