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Completed

NCT Number: NCT07395193

Comparative Evaluation of 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.

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Key information

Conditions

Tonsil Disease Tonsil Disorder

Age range

5 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medicana Bursa Hospital

Nilufer, Bursa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Surgery time

    Time frame: During surgery

Secondary outcomes

  1. Time to first solid food intake

    Time frame: Within the first postoperative week

  2. Length of hospital stay

    Time frame: Postoperative Day 1

    Duration of hospitalization measured in days following tonsillectomy.

  3. Postoperative bleeding

    Time frame: Up to 30 days postoperatively

  4. Device cost per case

    Time frame: Perioperative period (day of surgery)

    Cost of the surgical device used for tonsillectomy, calculated per patient.

Sponsors and collaborators

Lead sponsor

Medicana Bursa Hospital

Other

Registry information

Official study title

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

Acronym: BCB-Tonsillect

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2026
Registry last updated
Feb 10, 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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