NCT07842419

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

May 1, 2021

Enrollment Period

3.7 years

First QC Date

May 16, 2021

Last Update Submit

September 21, 2026

Conditions

ENT DiseaseTonsil DiseaseSurgery

Keywords

TonsillectomyBizactTechniquePostoperative painPostoperative hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 2 weeks after surgery

Secondary Outcomes (3)

  • Usage of pain medication

    14 days postoperatively

  • Incidence of primary hemorrhage

    24 hours postoperatively

  • Incidence of secondary hemorrhage

    from 24 hours to 14 days postoperatively

Study Arms (3)

Bizact tonsillectomy

ACTIVE COMPARATOR

Patients operated with Bizact® instrument

Device: Tonsillectomy

Conventional tonsillectomy

ACTIVE COMPARATOR

Patient operated with conventional technique (bipolar cautery and scissors)

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)

Device: Tonsillectomy

Interventions

TonsillectomyDEVICE

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

Bizact tonsillectomyBizact-ConventionalConventional tonsillectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Otorhinolaryngologic DiseasesPain, PostoperativePostoperative Hemorrhage

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHemorrhage

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 16, 2021

First Posted

September 25, 2026

Study Start

March 1, 2021

Primary Completion

October 31, 2024

Study Completion

December 31, 2025

Last Updated

September 25, 2026

Record last verified: 2021-05

Locations

FI(1)