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

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

Interventions

PROCEDURE

BiZact

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.

PROCEDURE

Cold Steel

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

Sponsors & Collaborators

• Sygehus Lillebaelt

  collaborator OTHER

• Sonderborg Hospital

  collaborator OTHER_GOV

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Line Schiøtt Nissen

  lead OTHER

Principal Investigators

• Line S Nissen, MD · Regional Hospital West Jutland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2024-07-25

Completion

2025-01-21

Countries

• Denmark

Study Locations