Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606262
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis A Randomized Controlled Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background recurrent acute tonsillitis RT is a frequent condition affecting teenagers and adults Patients suffer from recurring throat symptoms fever and impaired quality of life QOL Tonsillectomy TE is the only well-known treatment but studies indicate that tonsillotomy TO is associated with less morbidity eg pain and bleeding and equal efficiency eg reduced number of sore throat episodes and improved QOL The investigator aim to clarify whether TO is a non-inferior alternative to TE
Methods inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up Comparisons will be made between groups and outcome measures includes number of sore throat episodes QOL and postoperative pain
Discussion the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure TO associated with less discomfort and risk than the current standard procedure TE and a presumably low risk of insufficiency
Methods inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up Comparisons will be made between groups and outcome measures includes number of sore throat episodes QOL and postoperative pain
Discussion the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure TO associated with less discomfort and risk than the current standard procedure TE and a presumably low risk of insufficiency
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None