- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07763704
The Impact of Tonsillectomy Techniques on Secondary Tonsillectomy Bleeding
August 10, 2026 updated by: Mariam Elia Saeed, Assiut University
Post-tonsillectomy hemorrhage (PTH) is one of the most common and potentially life-threatening complications of tonsillectomy.
- Secondary PTH (Bleeding occurring >24 hours post-operatively) is of particular clinical significance.
- Tonsillectomy is a frequently performed procedure at Assiut University Hospital (AUH).
- However, no local prospective data exists comparing secondary PTH rates across techniques, or systematically characterizing its causes.
- This study addresses this gap by comparing rates, and analysis of causes.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Secondary PTH (bleeding >24 hours post-tonsillectomy)
Description
Inclusion Criteria:
- Secondary PTH (bleeding >24 hours post-tonsillectomy)
- Tonsillectomy surgical technique: cold steel, bipolar diathermy, or Coblation
- Any patient age (pediatric and adult patient are included)
- Presenting to the AUH Emergency Department or ENT clinic
Informed consent obtained (written parental consent + written child assent for patients under 18 years)
Exclusion Criteria:
- Primary PTH (bleeding ≤24 hours post-op)
- Tonsillectomy technique other than the three study techniques (e.g., laser, harmonic scalpel)
- External approach tonsillectomy
- Known bleeding disorder (pre-existing coagulopathy)
- Concurrent head and neck malignancy
- Refusal of informed consent
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
Cohorts and Interventions
Group / Cohort |
|---|
|
study group
Secondary PTH (bleeding >24 hours post-tonsillectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
secondary post-tonsillectomy hemorrhage
Time Frame: 10 day
|
bleeding from the throat that happens more than 24 hours after surgery, most commonly between 5 and 10 days post-op
|
10 day
|
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 (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 10, 2026
First Submitted That Met QC Criteria
August 10, 2026
First Posted (Actual)
August 13, 2026
Study Record Updates
Last Update Posted (Actual)
August 13, 2026
Last Update Submitted That Met QC Criteria
August 10, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2ry tonsillectomy bleeding
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.