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Completed

NCT Number: NCT03984851

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.

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Key information

Conditions

Tonsil; Injury Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Blood Loss Wounds and Injuries

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary Post-operative tonsillectomy bleeding

    Time frame: 24 hours post-op

    Bleeding due to the surgical procedure within 24 hours from the surgery

  2. Secondary Post-operative Tonsillectomy bleeding

    Time frame: after 24 hours

    Bleeding due to the surgical procedure after 24 hours from the surgery

Sponsors and collaborators

Lead sponsor

Dr. Abdul Mohsen Ibrahim Al-Turki Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 13, 2019
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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