Hemostasis Using Surgicel in Pediatric Tonsillectomy

Completed

• Conditions: Tonsil; Injury; Surgical Blood Loss

• Registration Number: NCT03984851
• Lead Sponsor: Dr. Abdul Mohsen Ibrahim Al-Turki Clinic

Brief Summary

Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.

The goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy. The patient that were enrolled in this retrospective study were patients who underwent tonsillectomy and achieved hemostasis either by Surgicel (group A) or bipolar cautery (group B). Our results showed that there was no statistical significant difference between the two techniques in terms of post-operative bleeding events.

Detailed Description

Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.

The goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy.

The study was a retrospective cohort in three tertiary care centers in xxxx, from January 2016 to August 2018. All patients underwent at least tonsillectomy, with a proportion undergoing additional adenoidectomy, myringotomy, or tube insertion as indicated, were enrolled in the study. Patients were stratified to 2 groups according to the surgeons preference for the hemostasis technique, one was subjected to cold dissection tonsillectomy and achieved hemostasis via the application of Surgicel to the surgical site, and the other underwent cold dissection tonsillectomy and attained hemostasis through bipolar cautery.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-08-01
• Study Completion: 2019-01-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-12
• Last Update Submitted: 2019-06-12
• Study First Posted: 2019-06-13
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• Patients under age of 12, diagnosed with recurrent tonsillitis or OSA and are candidates for tonsillectomy
• patients must have went tonsillectomy

Exclusion Criteria

• age more than 12

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Post-operative tonsillectomy bleeding	24 hours post-op	Bleeding due to the surgical procedure within 24 hours from the surgery
Secondary Post-operative Tonsillectomy bleeding	after 24 hours	Bleeding due to the surgical procedure after 24 hours from the surgery