Tonsillectomy and Risk of Post-Tonsillectomy Hemorrhage

NCT05161754 | Completed DMC

• 1 other identifier: H-20036864
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 2

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.

Conditions

Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• Number of bleeding episodes

  Number of bleeding episodes from each tonsilbed.

  Postoperative day 0 to 30

Secondary Outcomes (1)

• Pain perception

  Postoperative day 0 to 30

Study Arms (2)

Treatment 1

EXPERIMENTAL

Participants left tonsil: cold dissection and hot hemostasis. Participants right tonsil: cold dissection and cold hemostasis.

Procedure: Hemostasis

Treatment 2

EXPERIMENTAL

Participants right tonsil: cold dissection and hot hemostasis. Participants left tonsil: cold dissection and cold hemostasis.

Procedure: Hemostasis

Interventions

Hemostasis PROCEDURE

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

Treatment 1; Treatment 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (2)

Charlottenlund Privat Hospital

Charlottenlund, 2920, Denmark

Location

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (8)

• 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.

  PMID: 28851039 BACKGROUND

• Kvaerner KJ. Benchmarking surgery: secondary post-tonsillectomy hemorrhage 1999-2005. Acta Otolaryngol. 2009 Feb;129(2):195-8. doi: 10.1080/00016480802078101.

  PMID: 18607926 BACKGROUND

• Blomgren 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.

  PMID: 11224779 BACKGROUND

• Gysin 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.

  PMID: 23978795 BACKGROUND

• Juul MLB, Rasmussen ER, Howitz MF. Incidence of post-tonsillectomy haemorrhaging in Denmark. Dan Med J. 2020 Aug 1;67(8):A11190640.

  PMID: 32741442 BACKGROUND

• Soderman 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.

  PMID: 25515059 BACKGROUND

• Lowe 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.

  PMID: 15325834 BACKGROUND

• Wulu 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.

  PMID: 30611028 BACKGROUND

MeSH Terms

Interventions

Hemostasis

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Michael Frantz Howitz, MD, PhD

  North Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: March 28, 2022
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)