Hemostasis Using Surgicel in Pediatric Tonsillectomy

Surgical Blood Loss Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984851
• Other study ID #: Al-Terki Clinic
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: June 2019
• Source: Dr. Abdul Mohsen Ibrahim Al-Turki Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 1, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Surgical Blood Loss
• Tonsil; Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Abdul Mohsen Ibrahim Al-Turki Clinic

Outcome

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