Tonsil; InjuryNCT03984851
Hemostasis Using Surgicel in Pediatric Tonsillectomy
An observational study of Tonsil; Injury and Surgical Blood Loss, run by Dr. Abdul Mohsen Ibrahim Al-Turki Clinic.
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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Tonsil; Injury, Surgical Blood Loss
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Patients under age of 12, diagnosed with recurrent tonsillitis or OSA and are candidates for tonsillectomy
- patients must have went tonsillectomy
Who cannot join
- age more than 12
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 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.
- Conditions
- Tonsil; Injury, Surgical Blood Loss
- Keywords
- tonsillectomy, primary hemostasis tonsillectomy, surgicel
- Medical subject headings
- Wounds and Injuries, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Post-operative tonsillectomy bleeding
Bleeding due to the surgical procedure within 24 hours from the surgery
Measured: 24 hours post-op
Secondary Post-operative Tonsillectomy bleeding
Bleeding due to the surgical procedure after 24 hours from the surgery
Measured: after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Jan 2016
- Primary completion1 Aug 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsil; InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Abdul Mohsen Ibrahim Al-Turki Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulmohsen Al-Terki, Dr. Abdul Mohsen Ibrahim Al-Turki Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984851
- Sponsor's protocol ID
- Al-Terki Clinic
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis Using Surgicel in Pediatric Tonsillectomy
- ClinicalTrials.gov ID
- NCT03984851
- Acronym / sponsor ID
- Al-Terki Clinic
- Conditions
- Tonsil; Injury, Surgical Blood Loss
- Keywords
- tonsillectomy, primary hemostasis tonsillectomy, surgicel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Dr. Abdul Mohsen Ibrahim Al-Turki ClinicUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- Patients under age of 12, diagnosed with recurrent tonsillitis or OSA and are candidates for tonsillectomy
- patients must have went tonsillectomy
Key exclusion criteria (1 listed)
- age more than 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Post-operative tonsillectomy bleeding
Time frame: 24 hours post-op
Bleeding due to the surgical procedure within 24 hours from the surgery
Secondary Post-operative Tonsillectomy bleeding
Time frame: after 24 hours
Bleeding due to the surgical procedure after 24 hours from the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsil; Injury and Surgical Blood Loss, run by Dr. Abdul Mohsen Ibrahim Al-Turki Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Post-operative tonsillectomy bleeding (time frame: 24 hours post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.