Trials / Active Not Recruiting
Active Not RecruitingNCT06937762
Coblation Tonsillotomy Versus Radiofrequency and Cold Knife Dissection Tonsillectomy
Intracapsular Coblation Tonsillotomy Versus Extracapsular Radiofrequency and Cold Knife Dissection Tonsillectomy
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Kafrelsheikh University · Academic / Other
- Sex
- All
- Age
- 3 Years – 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Timeline
- Start date
- 2025-04-20
- Primary completion
- 2025-09-01
- Completion
- 2025-09-15
- First posted
- 2025-04-22
- Last updated
- 2025-09-16
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT06937762. Inclusion in this directory is not an endorsement.