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NCT Number: NCT07842419

Bizact Tonsillectomy: Postoperative Pain, Bleeding and Cost-effectiveness (Randomized Study)

Randomized trial assessing Bizact-instrument in tonsillectomy and it's impact on postoperative recovery (pain, hemorrhage)

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Key information

Conditions

ENT Disease Hemorrhage Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Signs and Symptoms Surgery Tonsil Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, 00029, Finland

About this study

Bizact is an electrosurgical instrument developed for tonsillectomy. Bizact causes less thermal damage to tissues than traditional bipolar coagulation, and thus is assumed, that using Bizact might lead to faster and less painful recovery. Furthermore, incidence of postoperative hemorrhage is assumed to be lower.

The study evaluates the usability of Bizact and it's impact on postoperative pain, the occurrence of secondary postoperative hemorrhage, and the total costs of surgery compared with traditional bipolar tonsillectomy.

We recruit 225 patients who are randomized into three groups.

  • both tonsils are removed with Bizact
  • both tonsils are removed with traditional method using bipolar cautery and scissors
  • one tonsil is removed with Bizact ant the other with bipolar cautery and scissors Patients are blinded with respect to group. Postoperative recovery is monitored on a daily basis with a questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tonsillectomy due to chronic tonsillitis or tonsillar hypertrophy
  • Age ≥18 years

Exclusion criteria

  • Unilateral tonsillectomy
  • History of peritonsillar abscess
  • Coagulation disorder or ongoing anticoagulation therapy
  • Re-tonsillectomy
  • Additional simultaneous procedure

Treatment and study plan

Tonsillectomy

Device

Tonsillectomy is performed with Bizact®, or bipolar cautery and scissors, or both

Primary outcomes

  1. Patient reported intensity of postoperative pain in numeric rating scale (0-10) on postoperative days 1-14

    Time frame: within 2 weeks after surgery

    Patients receive a questionnaire to assess their recovery during the first 14 postoperative days. Pain is evaluated separately for each side every morning before taking any analgesics and reported using a numeric rating scale 0-10.

Secondary outcomes

  1. Usage of pain medication

    Time frame: 14 days postoperatively

    Patients document their daily use of pain medication in the postoperative questionnaire.

  2. Incidence of primary hemorrhage

    Time frame: 24 hours postoperatively

    Incidence of postoperative hemorrhage within 24 hours of surgery

  3. Incidence of secondary hemorrhage

    Time frame: from 24 hours to 14 days postoperatively

    Incidence of secondary postoperative hemorrhage warranting hospital contact and confirmed by an examination, graded by severity according to the Stammberger classification.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Bizact Tonsillectomy in Adults - Randomized Study Assigning Postoperative Pain, Bleeding and Cost-effectiveness

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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