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Comparative Evaluation of BiZact™, Coblation, and Bipolar Tonsillectomy Techniques

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07395193
Acronym
BCB-Tonsillect
Enrollment
150
Registered
2026-02-09
Start date
2024-11-29
Completion date
2025-09-29
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsil Disease, Tonsil Disorder

Keywords

tonsillectomy

Brief summary

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.

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.

Interventions

None listed

Sponsors

Medicana Bursa Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain (Visual Analog Scale score)Postoperative days 1, 3, and 7Postoperative 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.
Surgery timeDuring surgery

Secondary

MeasureTime frameDescription
Postoperative bleedingUp to 30 days postoperatively
Length of hospital stayPostoperative Day 1Duration of hospitalization measured in days following tonsillectomy.
Time to first solid food intakeWithin the first postoperative week
Device cost per casePerioperative period (day of surgery)Cost of the surgical device used for tonsillectomy, calculated per patient.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026