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CompletedNCT03984851Updated Jun 13, 2019

Hemostasis Using Surgicel in Pediatric Tonsillectomy

An observational study in Tonsil; Injury and Surgical Blood Loss, sponsored by Dr. Abdul Mohsen Ibrahim Al-Turki Clinic. Completed. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by Dr. Abdul Mohsen Ibrahim Al-Turki Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
203
Ages
Up to 12 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Tonsil; Injury
  • Surgical Blood Loss

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Keywords

  • tonsillectomy
  • primary hemostasis tonsillectomy
  • surgicel
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In context

Blood Loss, Surgical

218 studies on the registry are indexed under Blood Loss, Surgical; 39 are open to participants now.

This study's enrollment of 203 is above the median of 154 across 49 observational studies indexed under Blood Loss, Surgical.

Browse Blood Loss, Surgical studies →

Lead sponsor

This is the only study on the registry with Dr. Abdul Mohsen Ibrahim Al-Turki Clinic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • age more than 12
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
203 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Primary Post-operative tonsillectomy bleeding

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

    Time frame: 24 hours post-op

  2. Secondary Post-operative Tonsillectomy bleeding

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

    Time frame: after 24 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03984851
Lead sponsor
Dr. Abdul Mohsen Ibrahim Al-Turki Clinic
Responsible party
Abdulmohsen Al-Terki (Dr. Abdulmohsen Al-Terki, Dr. Abdul Mohsen Ibrahim Al-Turki Clinic) — Principal investigator
First posted
Jun 13, 2019
Start date
Jan 1, 2016
Primary completion
Aug 1, 2018
Completion
Jan 1, 2019
Last update
Jun 13, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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