TonsillectomyNCT05161754
Tonsillectomy and Risk of Post-Tonsillectomy Hemorrhage
A study testing Hemostasis in people with Tonsillectomy, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial summary
Post-tonsillectomy hemorrhage (PTH) is a feared complication to tonsillectomy. Tonsillectomy may be performed using different surgical techniques, which include both "cold" and "hot" dissection and hemostasis - but the technique may have a great impact on the risk of PTH. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tonsillectomy
- What is being tested?
- Hemostasis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 2 sitesDenmark
- Study dates
- 28 Mar 2022to 28 Nov 2024
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients at the age of 12 years or older referred for tonsillectomy from a medical doctor will be asked to participate.
Who cannot join
- Patients under the age of 12 years.
- If using prescriptive anticoagulations.
- If known with a coagulopathy.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Charlottenlund Privat Hospital
Charlottenlund, 2920
Nordsjaellands Hospital
Hillerød, 3400
About this study
Official title: Tonsillectomy and Risk of Post-tonsillectomy Hemorrhage - a Randomized Clinical Trial
Post-tonsillectomy hemorrhage (PTH) is a feared complication to tonsillectomy. Tonsillectomy may be performed using different surgical techniques, which include both "cold" and "hot" dissection and hemostasis - but the technique may have a great impact on the risk of PTH. As of today there is no standard on how to perform hemostasis during tonsillectomy in Denmark.
The aim of this study is to clarify whether cold dissection with either cold or hot hemostasis during the surgical procedure of tonsillectomy holds the lowest risk of PTH. Secondary objective is to address whether there is a difference in pain perception associated with the two procedures. The null hypothesis is that there is no difference in PTH between cold and hot hemostasis in tonsillectomy.
Read the detailed description
Tonsillectomy is one of the most common procedures in the field of otorhinolaryngology, and in 2012 the yearly incidence was 129,4 per 100.000 inhabitants in Denmark. One feared complication among patients as well as physicians is post-tonsillectomy hemorrhage (PTH). The PTH incidence varies between 0,5 to 33 procent in reported studies, and an increased incidence from 1991 to 2012 has been showed in a Danish study.
PTH is in the literature typically divided into a primary PTH occurring within 24 hours of tonsillectomy and a secondary PTH occurring in a bell-shaped incidence curve from day one after tonsillectomy to normally no risk 14 days after tonsillectomy when the tonsil eschar is discharged, and the tonsil bed is healed. The highest incidence of PTH is on day 0 and day 6.
The risk of PTH has been studied for the different surgical techniques. Both dissection and hemostasis may be performed by a "cold" or "hot" procedure, with the latter referring to the use of a heated instrument (coblation, diathermy, harmonic scalpel, various lasers ect.).
Cold dissection with no heated hemostasis is associated with the overall lowest risk of delayed PTH in a Swedish study. They showed that the risk of delayed PTH increases with the use of a bipolar diathermy for dissection and further increased if used for hemostasis in the tonsil bed.
A multicenter study from England and Northern Ireland found an over-all risk of PTH at 3.3 procent. The highest risk of PTH was found when hot technique was applied for both dissection and hemostasis, the relative risk of PTH was 3.1, comparing to a relative risk of 2.2 when dissection was conducted with cold steel and diathermy. Reference was cold steel tonsillectomy alone. Coblation held the highest risk (3.4).
A review article from 2019 on ten published articles (n=3,987) concludes that suturing tonsil pillars after tonsillectomy may be beneficial to lower PTH after cold tonsillectomy. Five studies looked at postoperative pain reduction after tonsil pillar suturing and the conclusion is that this will likely need further investigation, as there are many factors that can influence pain perception. The operation time increased with in average eight minutes when performing suture on the tonsil pillar, basis and/or bed.
In Denmark there is no standard on how to perform hemostasis during tonsillectomy. It is up to the surgeon to choose. In Denmark anno 2020 and at least the past two decades the preferred techniques have been cold dissection of the tonsil, some use knotting of the tonsil pillar, while other use diathermy on the tonsil pillar and most perform secondary hot diathermy of the tonsil bed to acquire hemostasis per-operatively.
Randomized clinical trials are regarded as the best way to study the safety and efficacy of a treatment. To our knowledge, from search at Pubmed.gov, clinicaltrials.gov and clinicaltrialsregister.eu a similar study has not been conducted and no similar study is registered undergoing elsewhere. Following, we would like to initiate this randomized clinical trial to clarify which hemostasis procedure has the overall lowest risk of PTH. Results from a study like this will be important scientific input in an ongoing discussion among Ear, nose and throat doctors and of beneficial for future patients undergoing tonsillectomy.
In short, the surgeon is randomly instructed to conduct normal procedure (cold dissection and bipolar diathermy) on one tonsil, and on the other tonsil use cold dissection and cold hemostasis (surgical knotting of the tonsil pillar and compression). Our endpoints are primary and secondary PTH and pain perception.
- Conditions
- Tonsillectomy
- Being tested
- Hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemostasisProcedure or surgery
Hot hemostasis include bipolar and monopolar diathermy. Cold hemostasis include surgical knotting of the tonsil pillar and compression.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Participants left tonsil: cold dissection and hot hemostasis. Participants right tonsil: cold dissection and cold hemostasis. Receives: Procedure: Hemostasis |
| Treatment 2 | Experimental | Participants right tonsil: cold dissection and hot hemostasis. Participants left tonsil: cold dissection and cold hemostasis. Receives: Procedure: Hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding episodes
Number of bleeding episodes from each tonsilbed.
Measured: Postoperative day 0 to 30
Secondary outcomes (1)
Pain perception
Pain Scores on the Visual Analog Scale (VAS)- for the left and right throat side respectively. The VAS ranges from 0 to 10, with 0 indicating no pain and higher scores indicating greater pain.
Measured: Postoperative day 0 to 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start28 Mar 2022
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael F Howitz, Nordsjaellands Hospital
- Investigators
- Michael Frantz Howitz, MD, PhD, Principal investigator, North Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161754
- Sponsor's protocol ID
- H-20036864
- Status last verified
- May 2025
- First submitted
- 3 Dec 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Juul ML, Rasmussen ER, Rasmussen SHR, Sorensen CH, Howitz MF. A nationwide registry-based cohort study of incidence of tonsillectomy in Denmark, 1991-2012. Clin Otolaryngol. 2018 Feb;43(1):274-284. doi: 10.1111/coa.12959. Epub 2017 Sep 13.
PubMed 28851039Kvaerner KJ. Benchmarking surgery: secondary post-tonsillectomy hemorrhage 1999-2005. Acta Otolaryngol. 2009 Feb;129(2):195-8. doi: 10.1080/00016480802078101.
PubMed 18607926Blomgren K, Qvarnberg YH, Valtonen HJ. A prospective study on pros and cons of electrodissection tonsillectomy. Laryngoscope. 2001 Mar;111(3):478-82. doi: 10.1097/00005537-200103000-00018.
PubMed 11224779Gysin C, Dulguerov P. Hemorrhage after tonsillectomy: does the surgical technique really matter? ORL J Otorhinolaryngol Relat Spec. 2013;75(3):123-32. doi: 10.1159/000342314. Epub 2013 Aug 22.
PubMed 23978795Juul MLB, Rasmussen ER, Howitz MF. Incidence of post-tonsillectomy haemorrhaging in Denmark. Dan Med J. 2020 Aug 1;67(8):A11190640.
PubMed 32741442Soderman AC, Odhagen E, Ericsson E, Hemlin C, Hultcrantz E, Sunnergren O, Stalfors J. Post-tonsillectomy haemorrhage rates are related to technique for dissection and for haemostasis. An analysis of 15734 patients in the National Tonsil Surgery Register in Sweden. Clin Otolaryngol. 2015 Jun;40(3):248-54. doi: 10.1111/coa.12361.
PubMed 25515059Lowe D, van der Meulen J; National Prospective Tonsillectomy Audit. Tonsillectomy technique as a risk factor for postoperative haemorrhage. Lancet. 2004 Aug 21-27;364(9435):697-702. doi: 10.1016/S0140-6736(04)16896-7.
PubMed 15325834Wulu JA, Chua M, Levi JR. Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review. Int J Pediatr Otorhinolaryngol. 2019 Feb;117:204-209. doi: 10.1016/j.ijporl.2018.12.003. Epub 2018 Dec 4.
PubMed 30611028Howitz MF, Barfred M, Vilhelmsen FJ, Trolle W, Kirchmann M. Cold versus hot haemostasis in tonsillectomy: impact on post-tonsillectomy haemorrhage and pain perception - results from a randomized clinical trial. Eur Arch Otorhinolaryngol. 2026 May;283(5):3263-3273. doi: 10.1007/s00405-026-10027-z. Epub 2026 Mar 20.
PubMed 41862716
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonsillectomy and Risk of Post-tonsillectomy Hemorrhage - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05161754
- Acronym / sponsor ID
- H-20036864
- Conditions
- Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 17 Dec 2021 (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.
Post-tonsillectomy hemorrhage (PTH) is a feared complication to tonsillectomy. Tonsillectomy may be performed using different surgical techniques, which include both "cold" and "hot" dissection and hemostasis - but the technique may have a great impact on the risk of PTH. As of today there is no standard on how to perform hemostasis during tonsillectomy in Denmark.
The aim of this study is to clarify whether cold dissection with either cold or hot hemostasis during the surgical procedure of tonsillectomy holds the lowest risk of PTH. Secondary objective is to address whether there is a difference in pain perception associated with the two procedures. The null hypothesis is that there is no difference in PTH between cold and hot hemostasis in tonsillectomy.
Detailed description
Tonsillectomy is one of the most common procedures in the field of otorhinolaryngology, and in 2012 the yearly incidence was 129,4 per 100.000 inhabitants in Denmark. One feared complication among patients as well as physicians is post-tonsillectomy hemorrhage (PTH). The PTH incidence varies between 0,5 to 33 procent in reported studies, and an increased incidence from 1991 to 2012 has been showed in a Danish study.
PTH is in the literature typically divided into a primary PTH occurring within 24 hours of tonsillectomy and a secondary PTH occurring in a bell-shaped incidence curve from day one after tonsillectomy to normally no risk 14 days after tonsillectomy when the tonsil eschar is discharged, and the tonsil bed is healed. The highest incidence of PTH is on day 0 and day 6.
The risk of PTH has been studied for the different surgical techniques. Both dissection and hemostasis may be performed by a "cold" or "hot" procedure, with the latter referring to the use of a heated instrument (coblation, diathermy, harmonic scalpel, various lasers ect.).
Cold dissection with no heated hemostasis is associated with the overall lowest risk of delayed PTH in a Swedish study. They showed that the risk of delayed PTH increases with the use of a bipolar diathermy for dissection and further increased if used for hemostasis in the tonsil bed.
A multicenter study from England and Northern Ireland found an over-all risk of PTH at 3.3 procent. The highest risk of PTH was found when hot technique was applied for both dissection and hemostasis, the relative risk of PTH was 3.1, comparing to a relative risk of 2.2 when dissection was conducted with cold steel and diathermy. Reference was cold steel tonsillectomy alone. Coblation held the highest risk (3.4).
A review article from 2019 on ten published articles (n=3,987) concludes that suturing tonsil pillars after tonsillectomy may be beneficial to lower PTH after cold tonsillectomy. Five studies looked at postoperative pain reduction after tonsil pillar suturing and the conclusion is that this will likely need further investigation, as there are many factors that can influence pain perception. The operation time increased with in average eight minutes when performing suture on the tonsil pillar, basis and/or bed.
In Denmark there is no standard on how to perform hemostasis during tonsillectomy. It is up to the surgeon to choose. In Denmark anno 2020 and at least the past two decades the preferred techniques have been cold dissection of the tonsil, some use knotting of the tonsil pillar, while other use diathermy on the tonsil pillar and most perform secondary hot diathermy of the tonsil bed to acquire hemostasis per-operatively.
Randomized clinical trials are regarded as the best way to study the safety and efficacy of a treatment. To our knowledge, from search at Pubmed.gov, clinicaltrials.gov and clinicaltrialsregister.eu a similar study has not been conducted and no similar study is registered undergoing elsewhere. Following, we would like to initiate this randomized clinical trial to clarify which hemostasis procedure has the overall lowest risk of PTH. Results from a study like this will be important scientific input in an ongoing discussion among Ear, nose and throat doctors and of beneficial for future patients undergoing tonsillectomy.
In short, the surgeon is randomly instructed to conduct normal procedure (cold dissection and bipolar diathermy) on one tonsil, and on the other tonsil use cold dissection and cold hemostasis (surgical knotting of the tonsil pillar and compression). Our endpoints are primary and secondary PTH and pain perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Procedure: HemostasisParticipants left tonsil: cold dissection and hot hemostasis. Participants right tonsil: cold dissection and cold hemostasis. |
| Treatment 2 | Experimental | Procedure: HemostasisParticipants right tonsil: cold dissection and hot hemostasis. Participants left tonsil: cold dissection and cold hemostasis. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients at the age of 12 years or older referred for tonsillectomy from a medical doctor will be asked to participate.
Key exclusion criteria (3 listed)
- Patients under the age of 12 years.
- If using prescriptive anticoagulations.
- If known with a coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemostasisHot hemostasis include bipolar and monopolar diathermy. Cold hemostasis include surgical knotting of the tonsil pillar and compression. | Procedure or surgery | Treatment 1, Treatment 2 |
Primary outcome
Number of bleeding episodes
Time frame: Postoperative day 0 to 30
Number of bleeding episodes from each tonsilbed.
1 secondary outcome
Pain perception
Time frame: Postoperative day 0 to 30
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 29 May 2025.
- Background: PubMed 28851039Juul ML, Rasmussen ER, Rasmussen SHR, Sorensen CH, Howitz MF. A nationwide registry-based cohort study of incidence of tonsillectomy in Denmark, 1991-2012. Clin Otolaryngol. 2018 Feb;43(1):274-284. doi: 10.1111/coa.12959. Epub 2017 Sep 13.
- Background: PubMed 18607926Kvaerner KJ. Benchmarking surgery: secondary post-tonsillectomy hemorrhage 1999-2005. Acta Otolaryngol. 2009 Feb;129(2):195-8. doi: 10.1080/00016480802078101.
- Background: PubMed 11224779Blomgren K, Qvarnberg YH, Valtonen HJ. A prospective study on pros and cons of electrodissection tonsillectomy. Laryngoscope. 2001 Mar;111(3):478-82. doi: 10.1097/00005537-200103000-00018.
- Background: PubMed 23978795Gysin C, Dulguerov P. Hemorrhage after tonsillectomy: does the surgical technique really matter? ORL J Otorhinolaryngol Relat Spec. 2013;75(3):123-32. doi: 10.1159/000342314. Epub 2013 Aug 22.
- Background: PubMed 32741442Juul MLB, Rasmussen ER, Howitz MF. Incidence of post-tonsillectomy haemorrhaging in Denmark. Dan Med J. 2020 Aug 1;67(8):A11190640.
- Background: PubMed 25515059Soderman AC, Odhagen E, Ericsson E, Hemlin C, Hultcrantz E, Sunnergren O, Stalfors J. Post-tonsillectomy haemorrhage rates are related to technique for dissection and for haemostasis. An analysis of 15734 patients in the National Tonsil Surgery Register in Sweden. Clin Otolaryngol. 2015 Jun;40(3):248-54. doi: 10.1111/coa.12361.
- Background: PubMed 15325834Lowe D, van der Meulen J; National Prospective Tonsillectomy Audit. Tonsillectomy technique as a risk factor for postoperative haemorrhage. Lancet. 2004 Aug 21-27;364(9435):697-702. doi: 10.1016/S0140-6736(04)16896-7.
- Background: PubMed 30611028Wulu JA, Chua M, Levi JR. Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review. Int J Pediatr Otorhinolaryngol. 2019 Feb;117:204-209. doi: 10.1016/j.ijporl.2018.12.003. Epub 2018 Dec 4.
- Derived from this study: PubMed 41862716Howitz MF, Barfred M, Vilhelmsen FJ, Trolle W, Kirchmann M. Cold versus hot haemostasis in tonsillectomy: impact on post-tonsillectomy haemorrhage and pain perception - results from a randomized clinical trial. Eur Arch Otorhinolaryngol. 2026 May;283(5):3263-3273. doi: 10.1007/s00405-026-10027-z. Epub 2026 Mar 20.
- Individual participant dataSharing planned: No
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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.
Michael Frantz Howitz, MD, PhD principal investigator
North Zealand University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostasis in people with Tonsillectomy, run by Nordsjaellands Hospital at 2 sites in Denmark.
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 1 inclusion and 3 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Number of bleeding episodes (time frame: Postoperative day 0 to 30). 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 NCT05161754, which also lists 9 linked publications.
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 29 May 2025.