Hemostasis Using Surgicel in Pediatric Tonsillectomy

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.

Study Overview

• Status: Completed
• Conditions: Surgical Blood Loss; Tonsil; Injury

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 Type: Observational
• Enrollment (Actual): 203

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

any patient under the age of 12 who underwent tonsillectomy due to either recurrent tonsillitis or OSA by the 3 consultant otolaryngology surgeon authors in the study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A: Surgicel Group; a retrospective cohort study. Two groups were assigned, the first under the care of the author [AA], in which patients of his group underwent cold dissection tonsillectomy and achieved hemostasis via surgicel (without bipolar cautery). While group B patients (consisted of 2 surgeons) underwent cold dissection tonsillectomy and attained hemostasis with bipolar cautery. The main outcome that was pursued was postoperative tonsillectomy bleeding
Group B: Bipolar Cautery group; a retrospective cohort study. Two groups were assigned, the first under the care of the author [AA], in which patients of his group underwent cold dissection tonsillectomy and achieved hemostasis via surgicel (without bipolar cautery). While group B patients (consisted of 2 surgeons) underwent cold dissection tonsillectomy and attained hemostasis with bipolar cautery. The main outcome that was pursued was postoperative tonsillectomy bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Post-operative tonsillectomy bleeding	Bleeding due to the surgical procedure within 24 hours from the surgery	24 hours post-op
Secondary Post-operative Tonsillectomy bleeding	Bleeding due to the surgical procedure after 24 hours from the surgery	after 24 hours

Collaborators and Investigators

• Sponsor: Dr. Abdul Mohsen Ibrahim Al-Turki Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): August 1, 2018
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (ACTUAL): June 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: tonsillectomy; surgicel; primary hemostasis tonsillectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: Al-Terki Clinic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No