ENT DiseaseNCT07842419
Bizact Tonsillectomy: Postoperative Pain, Bleeding and Cost-effectiveness (Randomized Study)
A study testing Tonsillectomy in people with ENT Disease and Tonsil Disease, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Randomized trial assessing Bizact-instrument in tonsillectomy and it's impact on postoperative recovery (pain, hemorrhage) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ENT Disease, Tonsil Disease, Surgery
- What is being tested?
- Tonsillectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tonsillectomy due to chronic tonsillitis or tonsillar hypertrophy
- Age ≥18 years
Who cannot join
- Unilateral tonsillectomy
- History of peritonsillar abscess
- Coagulation disorder or ongoing anticoagulation therapy
- Re-tonsillectomy
- Additional simultaneous procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bizact Tonsillectomy in Adults - Randomized Study Assigning Postoperative Pain, Bleeding and Cost-effectiveness
Randomized trial assessing Bizact-instrument in tonsillectomy and it's impact on postoperative recovery (pain, hemorrhage)
Read the detailed description
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.
- Conditions
- ENT Disease, Tonsil Disease, Surgery
- Being tested
- Tonsillectomy
- Keywords
- Tonsillectomy, Bizact, Technique, Postoperative pain, Postoperative hemorrhage
- Medical subject headings
- Otorhinolaryngologic Diseases, Pain, Postoperative, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyDevice
Tonsillectomy is performed with Bizact®, or bipolar cautery and scissors, or both
| Study group | Role | What they receive |
|---|---|---|
| Bizact tonsillectomy | Active comparator | Patients operated with Bizact® instrument Receives: Device: Tonsillectomy |
| Conventional tonsillectomy | Active comparator | Patient operated with conventional technique (bipolar cautery and scissors) Receives: Device: Tonsillectomy |
| Bizact-Conventional | Active comparator | Side-controlled group, in which one tonsil is operated with Bizact® and another with conventional technique (bipolar cautery and scissors) Receives: Device: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported intensity of postoperative pain in numeric rating scale (0-10) on postoperative days 1-14
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.
Measured: within 2 weeks after surgery
Secondary outcomes (3)
Usage of pain medication
Patients document their daily use of pain medication in the postoperative questionnaire.
Measured: 14 days postoperatively
Incidence of primary hemorrhage
Incidence of postoperative hemorrhage within 24 hours of surgery
Measured: 24 hours postoperatively
Incidence of secondary hemorrhage
Incidence of secondary postoperative hemorrhage warranting hospital contact and confirmed by an examination, graded by severity according to the Stammberger classification.
Measured: from 24 hours to 14 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Mar 2021
- Primary completion31 Oct 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ENT DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Ruohoalho, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842419
- Sponsor's protocol ID
- Bizact tonsillectomy
- Status last verified
- May 2021
- First submitted
- 16 May 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bizact Tonsillectomy in Adults - Randomized Study Assigning Postoperative Pain, Bleeding and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT07842419
- Acronym / sponsor ID
- Bizact tonsillectomy
- Conditions
- ENT Disease, Tonsil Disease, Surgery
- Keywords
- Tonsillectomy, Bizact, Technique, Postoperative pain, Postoperative hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized trial assessing Bizact-instrument in tonsillectomy and it's impact on postoperative recovery (pain, hemorrhage)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bizact tonsillectomy | Active comparator | Device: TonsillectomyPatients operated with Bizact® instrument |
| Conventional tonsillectomy | Active comparator | Device: TonsillectomyPatient operated with conventional technique (bipolar cautery and scissors) |
| Bizact-Conventional | Active comparator | Device: TonsillectomySide-controlled group, in which one tonsil is operated with Bizact® and another with conventional technique (bipolar cautery and scissors) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tonsillectomy due to chronic tonsillitis or tonsillar hypertrophy
- Age ≥18 years
Key exclusion criteria (5 listed)
- Unilateral tonsillectomy
- History of peritonsillar abscess
- Coagulation disorder or ongoing anticoagulation therapy
- Re-tonsillectomy
- Additional simultaneous procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonsillectomyTonsillectomy is performed with Bizact®, or bipolar cautery and scissors, or both | Device | Bizact tonsillectomy, Bizact-Conventional, Conventional tonsillectomy |
Primary outcome
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.
3 secondary outcomes
Usage of pain medication
Time frame: 14 days postoperatively
Incidence of primary hemorrhage
Time frame: 24 hours postoperatively
Incidence of secondary hemorrhage
Time frame: from 24 hours to 14 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillectomy in people with ENT Disease and Tonsil Disease, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported intensity of postoperative pain in numeric rating scale (0-10) on postoperative days 1-14 (time frame: within 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.