Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques (BCB-Tonsillect)

February 8, 2026 updated by: Oktay Bulut, Medicana Bursa Hospital

A Prospective Observational Study Comparing BiZact™, Coblation, and Bipolar Tonsillectomy Techniques

This prospective, non-randomized observational study compared the surgical outcomes of BiZact™, Coblation, and Bipolar tonsillectomy techniques in pediatric and adult patients. Operative efficiency, postoperative pain, recovery parameters, postoperative bleeding, and device-related costs were evaluated.

Study Overview

Status

Completed

Conditions

Detailed Description

Tonsillectomy is a commonly performed surgical procedure in otorhinolaryngology, and various techniques have been developed to improve operative efficiency and postoperative recovery. This prospective, non-randomized observational study included 150 patients aged 5-40 years who underwent tonsillectomy between November 2024 and September 2025. Patients were allocated to Bipolar, Coblation, or BiZact tonsillectomy groups based on surgeon preference and device availability.

Primary outcome measures were operative time and postoperative pain assessed using the visual analogue scale on postoperative days 1, 3, and 7. Secondary outcomes included time to first solid food intake, length of hospital stay, postoperative bleeding, bleeding management, and device-related cost. The study aimed to compare clinical outcomes, recovery profiles, and procedural efficiency among the three tonsillectomy techniques.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric and adult patients undergoing tonsillectomy at a tertiary care center.

Description

Inclusion Criteria:

  • Age between 5 and 40 years
  • Undergoing tonsillectomy
  • Indication for surgery due to recurrent tonsillitis or obstructive sleep-related symptoms

Exclusion Criteria:

  • Known coagulation disorders
  • Presence of peritonsillar abscess
  • Presence of craniofacial syndromes
  • Incomplete follow-up data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
BiZact Tonsillectomy
Patients undergoing tonsillectomy using the BiZact™ device.
Coblation Tonsillectomy
Patients undergoing tonsillectomy using the coblation technique.
Bipolar Tonsillectomy
Patients undergoing tonsillectomy using bipolar electrocautery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain (Visual Analog Scale score)
Time Frame: Postoperative days 1, 3, and 7
Postoperative pain was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain intensity.
Postoperative days 1, 3, and 7
Surgery time
Time Frame: During surgery
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first solid food intake
Time Frame: Within the first postoperative week
Within the first postoperative week
Length of hospital stay
Time Frame: Postoperative Day 1
Duration of hospitalization measured in days following tonsillectomy.
Postoperative Day 1
Postoperative bleeding
Time Frame: Up to 30 days postoperatively
Up to 30 days postoperatively
Device cost per case
Time Frame: Perioperative period (day of surgery)
Cost of the surgical device used for tonsillectomy, calculated per patient.
Perioperative period (day of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicana Bursa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Bulut O, et al. Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques. Unpublished data.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2024

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

September 29, 2025

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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