Hemostasis Using Surgicel in Pediatric Tonsillectomy

NCT ID: NCT03984851

Last Updated: 2019-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Tonsil; Injury Surgical Blood Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Abdul Mohsen Ibrahim Al-Turki Clinic

OTHER

Sponsor Role lead

Responsible Party

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Abdulmohsen Al-Terki

Dr. Abdulmohsen Al-Terki

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Al-Terki Clinic

Identifier Type: -

Identifier Source: org_study_id

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