NCT06841432

Coblation Versus Suction Diathermy in Pediatric Adenoidectomy

Endoscopic Coblation Versus Suction Diathermy in Pediatric Adenoidectomy: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare two surgical procedures in endoscopic adenoidectomy including Coblation and Suction diathermy . The main questions it aims to answer are: Does the Coblation device have less time, less pain, less postoperative crustation and bad odor, less intraoperative bleeding, and less recurrence? Participants will: will undergo both procedures every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms

Conditions

• Adenoid Hypertrophy
• Adenoidectomy
• Coblation Adenoidectomy
• Suction Daithermy

Interventions

Type	Name	Description
PROCEDURE	adenoidectomy using coblatioion	One hundred and five patients underwent a Coblation-assisted adenoidectomy procedure. The child was positioned in Rose's position, which helped retract the soft palate and improve visibility of the nasopharynx. Two soft rubber catheters were inserted into the patient's mouth, with the distal and proximal ends crossed externally and secured with a clamp. The COBLATOR™ II surgery system Model EC8000-01 was used, with a power setting of nine for ablation and five for coagulation. Under general anesthesia, the adenoidectomy was performed using either a 4 mm, 70-degree angled endoscope inserted orally or a zero-degree endoscope inserted through the nose, providing effective visualization of the nasopharynx. After the procedure, hemostasis was achieved by using a combination of the coagulation and ablation modes.
PROCEDURE	adenoidectomy by Suction diathermy	One hundred and five patients underwent a suction diathermy adenoidectomy procedure. The soft palate was gently retracted using two suction catheters, allowing a 70-degree angled endoscope (Storz, Germany) placed in the oropharynx to provide a clear view of the adenoidal tissue and surrounding structures in the nasopharynx. Using a malleable size 10 or 12 French hand-switching suction coagulator, the adenoidal tissue was carefully ablated, starting from the uppermost part. The procedure was completed when the posterior choanae were clearly visible, and the nasopharynx had a smooth, unobstructed appearance. Great care was taken to avoid injuring the Eustachian tube orifice, posterior septum, choanae, inferior turbinate, palate, and posterior pharyngeal wall. Continuous irrigation with saline, either through the mouth or the nose, helped minimize any thermal damage caused by the diathermy machine.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: Egypt