NCT05270109

Cold Steel Versus "Hot" BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity

Completed NA Last updated 17 February 2025

What this trial tests

NA trial testing BiZact in Tonsillectomy in 1,250 participants. Completed in 21 January 2025.

Timeline

1 May 2022

Primary endpoint
25 July 2024

21 January 2025

Quick facts

Lead sponsor	Line Schiøtt Nissen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	1,250
Start date	1 May 2022
Primary completion	25 July 2024
Estimated completion	21 January 2025
Sites	1 location across Denmark

Drugs / interventions tested

• BiZact
• Cold Steel

Conditions studied

• Tonsillectomy — all drugs for Tonsillectomy →

Sponsor

Line Schiøtt Nissen

Who can join

Adults 4 to 100, any sex, with Tonsillectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tonsillectomy, with or without adenoidectomy, in both children and adults is worldwide one of the most commonly performed surgical procedures in otorhinolaryngology, and the number is increasing. Alone in Denmark, approximately 8.000 tonsillectomies are performed annually. Although, tonsillectomy on benign indication is considered to be a minor and frequently performed surgical procedure, the operation is associated with significant morbidity. Postoperative pain and post tonsillectomy haemorrhage (PTH) are the most frequent, and PTH is potentially life threatening. In cold steel tonsillectomy, the peritonsillar space is dissected with metal instruments, and bleeding is typically controlled by ligation or electrocautery. This method has been used for the past 50 years, and is considered the "Gold Standard". However, new so-called "hot techniques have been developed. One of these is an impedance-dependent tissue sealer device (BiZactTM). The equipment used for BiZactTM tonsillectomy is EC certificated (CE nr. 00500). The equipment is commonly used for tonsillectomy both internationally and in Denmark, and preliminary results in both adults and children are promising. However, when a gold standard technique is replaced by a new technique, it is recommended that the decision is based on evidence obtained in randomized controlled designs, and preferably as a multicenter study.

Within the scope of the CE marking of the equipment, the purpose of the present study is to conduct a randomized controlled trial (RCT) in order to investigate whether tonsillectomy performed with BiZactTM "hot" technique is beneficial or at least non-inferior compared to the gold standard cold steel technique in terms of affecting the incidence of post-tonsillectomy morbidity, interoperative factors, patient satisfaction, and health related quality of life.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cold steel versus impedance-dependent tissue sealer tonsillectomy - a study protocol for a randomised controlled trial.
   Nissen LS, Bertelsen J, Lyhne NM, Nielsen SH, et al · · 2023 · cited 1× · PMID 38018707
2. BiZact versus cold steel for post-tonsillectomy hemorrhage: a multicenter randomized trial.
   Mølhave M, Lyhne NM, Jensen DF, Nielsen SH, et al · · 2025 · PMID 41083818 · DOI 10.1007/s00405-025-09703-3