Prospective randomised controlled study comparing guillotine versus cold dissection tonsillectomy in children at Poole Hospital NHS Trust

ISRCTN ISRCTN27124658
DOI https://doi.org/10.1186/ISRCTN27124658
Protocol serial number N0186191632
Sponsor Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder Poole Hospital NHS Foundation Trust (UK) NHS R&D Support Funding
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
18/10/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Parmod K Jain
Scientific

Associate ENT Specialist
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom

Phone +44 01202 448290
Email parmod.jain@poole.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesTo demonstrate the perceived advantage of guillotine tonsillectomy versus cold steel dissection tonsillectomy in children.
Ethics approval(s)Added August 2008: Poole Hospital NHS Foundation Trust local ethics approval LREC no. 06/Q2201/49, 30/05/2006
Health condition(s) or problem(s) studiedSurgery: Tonsillectomy
InterventionGuillotine versus cold dissection tonsillectomy.
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date31/03/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit12 Years
SexNot Specified
Target sample size at registration100
Key inclusion criteriaChildren aged 3 to 12 undergoing a tonsillectomy.
Key exclusion criteria1. Previous quinsy
2. Bleeding clotting disorder
3. Concurrent adenoidectomy
Date of first enrolment08/03/2007
Date of final enrolment31/03/2010

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Associate ENT Specialist
Poole
BH15 2JB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2012 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes