Coblation Tonsillotomy Versus Radiofrequency and Cold Knife Dissection Tonsillectomy

NCT06937762 | Active Not Recruiting

• 1 other identifier: KFSIRB200-561
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Chronic Tonsillitis

Outcome Measures

Primary Outcomes (1)

• comparision of the severity of postoperative pain between the three groups.

  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

Study Arms (3)

Intra capsular coblation tonsillotomy

ACTIVE COMPARATOR

Device: Intra capsular coblation tonsillotomy

Extracapsular cold knife dissection tonsillectomy

ACTIVE COMPARATOR

Device: Extracapsular cold knife dissection tonsillectomy

Extra capsular Radiofrequency tonsillectomy

ACTIVE COMPARATOR

Device: Extra capsular Radiofrequency tonsillectomy

Interventions

Intra capsular coblation tonsillotomy DEVICE

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

Intra capsular coblation tonsillotomy

Extracapsular cold knife dissection tonsillectomy DEVICE

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

Extracapsular cold knife dissection tonsillectomy

Extra capsular Radiofrequency tonsillectomy DEVICE

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.

Extra capsular Radiofrequency tonsillectomy

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University Hospitals

Kafrelsheikh, Egypt

Location

Related Publications (2)

• Metcalfe C, Muzaffar J, Daultrey C, Coulson C. Coblation tonsillectomy: a systematic review and descriptive analysis. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2637-2647. doi: 10.1007/s00405-017-4529-4. Epub 2017 Mar 18.

  PMID: 28315933 BACKGROUND

• Liu Q, Zhang Y, Lyu Y. Postoperative hemorrhage following coblation tonsillectomy with and without suture: A randomized study in Chinese adults. Am J Otolaryngol. 2021 Jan-Feb;42(1):102760. doi: 10.1016/j.amjoto.2020.102760. Epub 2020 Oct 18.

  PMID: 33125902 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: April 20, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 15, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-04

Locations

EG (1)