Clinical trial NCT05280912: Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Official title: Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding Following Tonsillectomy (Disorder)
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases complicated by post-tonsillectomy bleeding

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

Eligibility 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:

Primary outcomes:
measure: new scoring system for possibility of post tonsillectomy bleeding
timeFrame: after 4 weeks post tonsillectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Hadir Gamal Mohamed
Study officials:
affiliation: sohag faculty of medicine
name: waleed AH mohammed, professor
role: STUDY_CHAIR
affiliation: sohag faculty of medicine
name: mohamed ER ahmed, doctor
role: STUDY_CHAIR
affiliation: sohag faculty of medicine
name: khaled G dahy, doctor
role: STUDY_CHAIR
References:
citation: 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.