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Hemostasis Using Surgicel in Pediatric Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03984851
Recruitment Status : Completed
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Abdulmohsen Al-Terki, Dr. Abdul Mohsen Ibrahim Al-Turki Clinic

Brief 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.


Condition or disease
Tonsil; Injury Surgical Blood Loss

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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Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Retrospective
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Tonsillitis

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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   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
Criteria

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

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Responsible Party: Abdulmohsen Al-Terki, Dr. Abdulmohsen Al-Terki, Dr. Abdul Mohsen Ibrahim Al-Turki Clinic
ClinicalTrials.gov Identifier: NCT03984851     History of Changes
Other Study ID Numbers: Al-Terki Clinic
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Abdulmohsen Al-Terki, Dr. Abdul Mohsen Ibrahim Al-Turki Clinic:
tonsillectomy
primary hemostasis tonsillectomy
surgicel

Additional relevant MeSH terms:
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Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications
Hemostatics
Coagulants