Cold Steel Versus Hot BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 100
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Denmark
Line Schiøtt Nissen
Recruiting
Gødstrup
Contact Information
Primary
Line S Nissen, MD
lineschioettnissen@gmail.com
+45 26741522
Backup
Therese Ovesen, MD, dr. med. prof.
theroves@rm.dk
Time Frame
Start Date: May 1, 2022
Estimated Completion Date: September 1, 2025
Participants
Target number of participants: 1250
Treatments
Experimental: BiZact
Active Comparator: Cold Steel
Authors
Line S Nissen
Related Therapeutic Areas
Sponsors
Collaborators: Hospital of South West Jutland, Aalborg University Hospital, Sonderborg Hospital, Sygehus Lillebaelt
Leads: Line Schiøtt Nissen

This content was sourced from clinicaltrials.gov

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