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

NCT05270109 | Completed

• 1 other identifier: 2202151
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tonsillectomy

Outcome Measures

Primary Outcomes (2)

• Incidence of PTH

  • Incidence of PTH defined as haemorrhage requiring haemostasis with; bipolar electric coagulation, ligature, compression and/or medical treatment with antifibrinolyticum within the first 24 hours after surgery until 30 days after surgery.

  24 hours until 30 days after surgery

• Postoperative pain

  • Postoperative pain assessed on a 11point numeric rating scale ranging from 0 "no pain" to 10 "worst possible pain". The Wong-Baker Faces rating scale is used for children.

  From the day of surgery until 14 days after the surgery

Secondary Outcomes (6)

• Blood loss

  Intraoperative

• Knife time

  First day of surgery

• PROM

  From the day of the surgery until 6 months after the surgery

• Unscheduled contacts to the health care system

  From the day of the surgery until 14 days after

• Health related quality of life

  From the day of the surgery until 6 months after the surgery

Study Arms (2)

BiZact

EXPERIMENTAL

Procedure: BiZact

Cold Steel

ACTIVE COMPARATOR

Procedure: Cold Steel

Interventions

BiZact PROCEDURE

In the "hot group" the peritonsillar space is dissected and sealed in one step by a bipolar instrument (BiZactTM). The instrument uses Valley Lab adjustable bipolar energy. Energy is automatically adjusted and delivered to the tissue in order minimize thermal tissue damage and seal blood vessels less than 3mm in diameter while dividing the soft tissue.

BiZact

Cold Steel PROCEDURE

In the "cold steel group" the peritonsillar space is dissected with metal instruments, and bleeding is typically controlled by ligation or electrocautery.

Cold Steel

Eligibility Criteria

• Age: 4 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Obstruction/ tonsillar hypertrophy.
• Recurrent tonsillitis, including previous peritonsillar abscess
• Chronic tonsillitis
• Systemic complications to tonsillitis (glomerulonephritis)
• Other (Mononucleosis), PFAPA (Periodic Fever, Aphtous stomatitis, pharyngitis, cervical adenitis)
• Foetor ex ore (tonsillar plugs)
• Peritonsillar abscess (Tonsillectomy a chaud)
• Ability to understand the written patient information and to give informed consent

You may not qualify if:

• Diseases in the hematopoietic system
• Antithrombotic or anticoagulant drugs in the recovery period
• Suspicion of/known tonsillar malignancies or other malignancy
• Patients or caregivers unable to read or speak Danish
• Patients or caregivers unable to use online application for self-evaluation

Sponsors & Collaborators

• Line Schiøtt Nissen: lead
• Sygehus Lillebaelt: collaborator
• Sonderborg Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Aalborg University Hospital: collaborator

Study Sites (1)

Line Schiøtt Nissen

Gødstrup, 7400, Denmark

Location

Related Publications (2)

• Molhave M, Lyhne NM, Jensen DF, Nielsen SH, Hahn P, Holm JK, Ovesen T, Bertelsen J. BiZact versus cold steel for post-tonsillectomy hemorrhage: a multicenter randomized trial. Eur Arch Otorhinolaryngol. 2025 Dec;282(12):6449-6457. doi: 10.1007/s00405-025-09703-3. Epub 2025 Oct 13.

  PMID: 41083818 DERIVED

• Nissen LS, Bertelsen J, Lyhne NM, Nielsen SH, Hahn P, Holm J, Ovesen T. Cold steel versus impedance-dependent tissue sealer tonsillectomy - a study protocol for a randomised controlled trial. Dan Med J. 2023 Nov 23;70(12):A06230366.

  PMID: 38018707 DERIVED

Study Officials

• Line S Nissen, MD

  Regional Hospital West Jutland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 8, 2022
• Study Start: May 1, 2022
• Primary Completion: July 25, 2024
• Study Completion: January 21, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)