Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
November 13, 2019 updated by: Hillel Yaffe Medical Center
comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 and over.
- patients with tonsillectomy indication due to chronic Tonsillitis.
Exclusion Criteria:
- patients with tonsillectomy indication without chronic tonsillitis ( due to other causes).
- chronic disease, chronic neurology disease.
- chronic psychology disease.
- bleeding tendency.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: patients with post - tonsillectomy suturing tonsil pillars
|
The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.
|
|
Placebo Comparator: patients without post - tonsillectomy suturing tonsil pillars
|
tonsillectomy without The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.
Time Frame: 1 year
|
two patients' group in this study , one group will have a Tonsil pillars suturing after the tonsillectomy and the second group will not have this technique after the tonsillectomy, then patience should answer a post pain tonsillectomy questionnaire , by the questionnaire and the checkups to compare how each group affected ( using SPSS program and Statistics Methods.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2019
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
November 7, 2019
First Submitted That Met QC Criteria
November 10, 2019
First Posted (Actual)
November 13, 2019
Study Record Updates
Last Update Posted (Actual)
November 14, 2019
Last Update Submitted That Met QC Criteria
November 13, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 077-19-HYMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.