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 |
| Secondary identifying numbers | N0186191632 |
- 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
Scientific
Associate ENT Specialist
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
| Phone | +44 01202 448290 |
|---|---|
| parmod.jain@poole.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | To 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) studied | Surgery: Tonsillectomy |
| Intervention | Guillotine versus cold dissection tonsillectomy. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 08/03/2007 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 12 Years |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | Children aged 3 to 12 undergoing a tonsillectomy. |
| Key exclusion criteria | 1. Previous quinsy 2. Bleeding clotting disorder 3. Concurrent adenoidectomy |
| Date of first enrolment | 08/03/2007 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Associate ENT Specialist
Poole
BH15 2JB
United Kingdom
BH15 2JB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Poole Hospital NHS Foundation Trust (UK) NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
