Coblation Tonsillotomy Versus Radiofrequency and Cold Knife Dissection Tonsillectomy

May 17, 2026 updated by: Ahmed Magdi Noaman Othman Orabi, Kafrelsheikh University

Intracapsular Coblation Tonsillotomy Versus Extracapsular Radiofrequency and Cold Knife Dissection Tonsillectomy

This study aims to assess and compare the outcomes between coblation intracapsular tonsillotomy versus extracapsular Radiofrequency and cold knife dissection tonsillectomy efficacy in managing patients requiring tonsil surgery as regards (time of operation, Intraoperative blood loss, postoperative pain, postoperative bleeding, complications, tonsillar fossa healing)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

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

  • Egypt
      • Kafrelsheikh, Egypt
        • Kafrelsheikh University Hospitals

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

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

Recurrent Acute tonsillitis Tonsillitis resulting in febrile convulsions Enlarged tonsils that cause upper airway obstruction, dysphagia, sleep disorders Chronic tonsillitis Chronic or recurrent tonsillitis in a streptococcal carrier not responding to beta-lactamase-resistant antibiotics

Exclusion criteria:

Patients with known bleeding disorders Acute infections of tonsil Contraindications for general anesthesia Anemia Patients unwilling or unable to give informed consent were excluded from this study patients

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intra capsular coblation tonsillotomy
Device: Intra capsular coblation tonsillotomy
Tonsils were dissected from the surface inward with the wand set at Coblate 7 setting. The wand skims the tonsil surface with continuous saline irrigation. Ablation was performed without penetrating the tonsillar capsule. Retraction of the tonsillar pillars is done to define the margins for near complete ablation. When the capsule is approached, the wand is turned down to Coblate 3 setting. Thin layer of tonsillar tissue is left to protect the capsule. Bleeding does not occur in most cases, but when it occurs, the wand was used in the Coagulate 5 setting for homeostasis
Active Comparator: Extracapsular cold knife dissection tonsillectomy
Device: Extracapsular cold knife dissection tonsillectomy
Begin by retracting the anterior tonsillar pillar to expose the tonsil, use a cold knife (scalpel or tonsil dissector) to make an incision along the anterior pillar near the mucosal margin of the tonsil, identify the plane between the tonsillar capsule and the underlying pharyngeal muscle, then carefully dissect the tonsil away from the surrounding tissues, following the plane to avoid trauma to the underlying structures, proceed from the superior pole of the tonsil to the inferior pole, ensuring that the entire tonsil is removed, use gauze or sponges to control minor bleeding during the procedure, for more significant bleeding, apply direct pressure or use ligatures and cold packs, achieve final hemostasis using absorbable sutures or electrocautery if needed
Active Comparator: Extra capsular Radiofrequency tonsillectomy
Device: Extra capsular Radiofrequency tonsillectomy
Radiofrequency bipolar forceps, connected to a radiofrequency apparatus model Ellman Surgitron 4 MHz (Ellman International, New York, USA) by which cutting and dissection with coagulation were done in the same time with minimal diffuse heating to the surrounding tissue. The power was adjusted to a power grade 40 in a bipolar mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparision of the severity of postoperative pain between the three groups.
Time Frame: The first time on day 1, the second time on day 3 and third time on day 7
1- Postoperative pain will be assessed using visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain)
The first time on day 1, the second time on day 3 and third time on day 7

Collaborators and Investigators

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

Sponsor

Kafrelsheikh University

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

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)

April 20, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSIRB200-561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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