Bleeding Following Tonsillectomy (Disorder)NCT05280912
Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
An observational study of Bleeding Following Tonsillectomy (Disorder), run by Sohag University at 1 site in Egypt.
Trial summary
factors associated with increase risk of post tonsillectomy hemorrhage and score of associated factors Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bleeding Following Tonsillectomy (Disorder)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cases complicated by post-tonsillectomy bleeding
Who may be able to join
None listed.
Who cannot join
- patient who have preoperative inherited bleeding disorder
- Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) riteria:
Trial locations and contacts
1 site in 1 country.
About this study
factors associated with increase risk of post tonsillectomy hemorrhage and score of associated factors
Read the detailed description
investigators review the medical records of patients who underwent tonsillectomy with or without adenoidectomy in our facility. None of the included patients had any known coagulopathy. The surgery was performed by several different surgeons, either otolaryngology residents or specialists, and using either cold or bipolar dissection. The procedures were performed under general anesthesia with orotracheal intubation. Bipolar electrocoagulation was used for hemostasis, as well as in some cases vicryl sutures. All medical records were reviewed according to age, gender, indications for tonsillectomy (tonsil hypertrophy causing upper airway obstruction, snoring or sleep apnea, chronic tonsillitis, peritonsillar abscess or suspected malignancy of the tonsils), coagulation profile [international normalized ratio (INR) and activated partial thromboplastin time values (aPTT)], type of surgery (tonsillectomy alone or adenotonsillectomy), surgical technique (cold or bipolar dissection), hemostasis method (bipolar electrocoagulation alone or electrocoagulation and sutures) and post-operative hemorrhage and its characterization. In this report, investigators will evaluate patients and collection of data to make a new scoring system that assesses patients according to several preoperative and postoperative factors to know the possibility of patients developing Post tonsillectomy hemorrhage. Post tonsillectomy hemorrhage is divided into two groups according to its severity: minimal hemorrhage that stopped spontaneously/after noninvasive treatment, and hemorrhage requiring reoperation for hemostasis revision in the operating room under general anesthesia.
Postoperative hemorrhage was defined as any bleeding requiring in hospital observation or treatment (medical, compression, cauterization under general anesthesia). Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) were not included in the group with post-operative hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
new scoring system for possibility of post tonsillectomy bleeding
investigators give a degree to the participants based on the factors they have as age and sex and accompanying to post tonsillectomy bleeding as increase white blood cells and anemia
Measured: after 4 weeks post tonsillectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bleeding Following Tonsillectomy (Disorder)Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Gamal Mohamed, Sohag University
- Investigators
- waleed AH mohammed, professor, Study chair, sohag faculty of medicinemohamed ER ahmed, doctor, Study chair, sohag faculty of medicinekhaled G dahy, doctor, Study chair, sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280912
- Sponsor's protocol ID
- HGMohamed
- Status last verified
- May 2023
- First submitted
- 18 Feb 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wall JJ, Tay KY. Postoperative Tonsillectomy Hemorrhage. Emerg Med Clin North Am. 2018 May;36(2):415-426. doi: 10.1016/j.emc.2017.12.009. Epub 2018 Feb 10.
PubMed 29622331
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With The Risk of Post Tonsillectomy Hemorrhage
- ClinicalTrials.gov ID
- NCT05280912
- Acronym / sponsor ID
- HGMohamed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 15 Mar 2022 (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.
factors associated with increase risk of post tonsillectomy hemorrhage and score of associated factors
Detailed description
investigators review the medical records of patients who underwent tonsillectomy with or without adenoidectomy in our facility. None of the included patients had any known coagulopathy. The surgery was performed by several different surgeons, either otolaryngology residents or specialists, and using either cold or bipolar dissection. The procedures were performed under general anesthesia with orotracheal intubation. Bipolar electrocoagulation was used for hemostasis, as well as in some cases vicryl sutures. All medical records were reviewed according to age, gender, indications for tonsillectomy (tonsil hypertrophy causing upper airway obstruction, snoring or sleep apnea, chronic tonsillitis, peritonsillar abscess or suspected malignancy of the tonsils), coagulation profile [international normalized ratio (INR) and activated partial thromboplastin time values (aPTT)], type of surgery (tonsillectomy alone or adenotonsillectomy), surgical technique (cold or bipolar dissection), hemostasis method (bipolar electrocoagulation alone or electrocoagulation and sutures) and post-operative hemorrhage and its characterization. In this report, investigators will evaluate patients and collection of data to make a new scoring system that assesses patients according to several preoperative and postoperative factors to know the possibility of patients developing Post tonsillectomy hemorrhage. Post tonsillectomy hemorrhage is divided into two groups according to its severity: minimal hemorrhage that stopped spontaneously/after noninvasive treatment, and hemorrhage requiring reoperation for hemostasis revision in the operating room under general anesthesia.
Postoperative hemorrhage was defined as any bleeding requiring in hospital observation or treatment (medical, compression, cauterization under general anesthesia). Patients who did not seek medical attention (e.g., patients with blood-tinged sputum or only minor bleeding) were not included in the group with post-operative hemorrhage
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases complicated by post-tonsillectomy bleeding
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
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
new scoring system for possibility of post tonsillectomy bleeding
Time frame: after 4 weeks post tonsillectomy
investigators give a degree to the participants based on the factors they have as age and sex and accompanying to post tonsillectomy bleeding as increase white blood cells and anemia
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 12 May 2023.
- Results publication: PubMed 29622331Wall JJ, Tay KY. Postoperative Tonsillectomy Hemorrhage. Emerg Med Clin North Am. 2018 May;36(2):415-426. doi: 10.1016/j.emc.2017.12.009. Epub 2018 Feb 10.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
waleed AH mohammed, professor study chair
sohag faculty of medicine
mohamed ER ahmed, doctor study chair
sohag faculty of medicine
khaled G dahy, doctor study chair
sohag faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding Following Tonsillectomy (Disorder), run by Sohag University at 1 site in Egypt.
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 0 inclusion and 2 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
new scoring system for possibility of post tonsillectomy bleeding (time frame: after 4 weeks post tonsillectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280912, which also lists 1 linked publication.
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 12 May 2023.