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History of Changes for Study: NCT05280912
Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Latest version (submitted March 14, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 14, 2022 None (earliest Version on record)
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Study NCT05280912
Submitted Date:  March 14, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: HGMohamed
Brief Title: Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Official Title: Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2022
Overall Status: Recruiting
Study Start: April 1, 2022
Primary Completion: April 1, 2022 [Anticipated]
Study Completion: June 1, 2023 [Anticipated]
First Submitted: February 18, 2022
First Submitted that
Met QC Criteria:
March 14, 2022
First Posted: March 15, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
March 14, 2022
Last Update Posted: March 15, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sohag University
Responsible Party: Principal Investigator
Investigator: Hadeer Gamal Mohamed
Official Title: resident of otorhinolaryngology
Affiliation: Sohag University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: factors associated with increase risk of post tonsillectomy hemorrhage and score of associated factors
Detailed Description:

investigators review the medical records of patients who underwent tonsillectomy with or without adenoidectomy in our facility. None of the included patients had any known coagulopathy. The surgery was performed by several different surgeons, either otolaryngology residents or specialists, and using either cold or bipolar dissection. The procedures were performed under general anesthesia with orotracheal intubation. Bipolar electrocoagulation was used for hemostasis, as well as in some cases vicryl sutures. All medical records were reviewed according to age, gender, indications for tonsillectomy (tonsil hypertrophy causing upper airway obstruction, snoring or sleep apnea, chronic tonsillitis, peritonsillar abscess or suspected malignancy of the tonsils), coagulation profile [international normalized ratio (INR) and activated partial thromboplastin time values (aPTT)], type of surgery (tonsillectomy alone or adenotonsillectomy), surgical technique (cold or bipolar dissection), hemostasis method (bipolar electrocoagulation alone or electrocoagulation and sutures) and post-operative hemorrhage and its characterization. In this report, investigators will evaluate patients and collection of data to make a new scoring system that assesses patients according to several preoperative and postoperative factors to know the possibility of patients developing Post tonsillectomy hemorrhage. Post tonsillectomy hemorrhage is divided into two groups according to its severity: minimal hemorrhage that stopped spontaneously/after noninvasive treatment, and hemorrhage requiring reoperation for hemostasis revision in the operating room under general anesthesia.

Postoperative hemorrhage was defined as any bleeding requiring in hospital observation or treatment (medical, compression, cauterization under general anesthesia). Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) were not included in the group with post-operative hemorrhage

Open or close this module Conditions
Conditions: Bleeding Following Tonsillectomy (Disorder)
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 30 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. new scoring system for possibility of post tonsillectomy bleeding
[ Time Frame: after 4 weeks post tonsillectomy ]

investigators give a degree to the participants based on the factors they have as age and sex and accompanying to post tonsillectomy bleeding as increase white blood cells and anemia
Open or close this module Eligibility
Study Population: All cases complicated by post-tonsillectomy bleeding
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:
  • Inclusion criteria : All cases complicated by post-tonsillectomy bleeding
    1. after elective or emergency tonsillectomy
    2. Primary Hge or secondary Hge
    3. regardless of age, the indication of surgery, surgical techniques
  • Exclusion criteria:
    1. patient who have preoperative inherited bleeding disorder
    2. Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) riteria:
Open or close this module Contacts/Locations
Central Contact Person: hadir GM Abd el megeed, resident
Telephone: 01029977533
Email: hadeer_gamal_post@med.sohag.edu.eg
Study Officials: waleed AH mohammed, professor
Study Chair
sohag faculty of medicine
mohamed ER ahmed, doctor
Study Chair
sohag faculty of medicine
khaled G dahy, doctor
Study Chair
sohag faculty of medicine
Locations: Egypt
Hadir Gamal Mohamed
[Recruiting]
Sohag, Egypt
Contact:Contact: hadir G mohamed, resident 01029977533 hadeer_gamal_post@med.sohag.edu.eg
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations: [Study Results] Wall JJ, Tay KY. Postoperative Tonsillectomy Hemorrhage. Emerg Med Clin North Am. 2018 May;36(2):415-426. doi: 10.1016/j.emc.2017.12.009. Epub 2018 Feb 10. Review. PubMed 29622331
Links: Description: Related Info
Available IPD/Information:

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