We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Factors Associated With The Risk of Post Tonsillectomy Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05280912
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : March 15, 2022
Information provided by (Responsible Party):
Hadeer Gamal Mohamed, Sohag University

Brief Summary:
factors associated with increase risk of post tonsillectomy hemorrhage and score of associated factors

Condition or disease
Bleeding Following Tonsillectomy (Disorder)

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Estimated Study Start Date : April 1, 2022
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Tonsillitis

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All cases complicated by post-tonsillectomy bleeding
  • 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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05280912

Layout table for location contacts
Contact: hadir GM Abd el megeed, resident 01029977533 hadeer_gamal_post@med.sohag.edu.eg

Layout table for location information
Hadir Gamal Mohamed Recruiting
Sohag, Egypt
Contact: hadir G mohamed, resident    01029977533    hadeer_gamal_post@med.sohag.edu.eg   
Sponsors and Collaborators
Sohag University
Layout table for investigator information
Study Chair: waleed AH mohammed, professor sohag faculty of medicine
Study Chair: mohamed ER ahmed, doctor sohag faculty of medicine
Study Chair: khaled G dahy, doctor sohag faculty of medicine
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Hadeer Gamal Mohamed, resident of otorhinolaryngology, Sohag University
ClinicalTrials.gov Identifier: NCT05280912    
Other Study ID Numbers: HGMohamed
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes