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Tonsillectomy and Risk of Post-Tonsillectomy Hemorrhage

Tonsillectomy and Risk of Post-tonsillectomy Hemorrhage - a Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05161754
Enrollment
358
Registered
2021-12-17
Start date
2022-03-28
Completion date
2024-11-28
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillectomy

Brief 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. 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.

Interventions

PROCEDUREHemostasis

Hot hemostasis include bipolar and monopolar diathermy. Cold hemostasis include surgical knotting of the tonsil pillar and compression.

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients at the age of 12 years or older referred for tonsillectomy from a medical doctor will be asked to participate.

Exclusion criteria

* Patients under the age of 12 years. * If using prescriptive anticoagulations. * If known with a coagulopathy.

Design outcomes

Primary

MeasureTime frameDescription
Number of bleeding episodesPostoperative day 0 to 30Number of bleeding episodes from each tonsilbed.

Secondary

MeasureTime frameDescription
Pain perceptionPostoperative day 0 to 30Pain 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026