Coblation Versus Suction Diathermy in Pediatric Adenoidectomy

Al-Azhar University

Status: Completed

Conditions: Coblation Adenoidectomy; Adenoidectomy; Suction Daithermy; Adenoid Hypertrophy

Treatments: Procedure: adenoidectomy by Suction diathermy; Procedure: adenoidectomy using coblatioion

Study type: Interventional

Funder types: Other

Identifiers

NCT06841432

MSCAZASTENT03028

Details and patient eligibility

About

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

Enrollment: 245 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients aged 2 to 18 years
• patients who had isolated adenoid hypertrophy
• patients' hemoglobin levels above 10 mg/dl

Exclusion criteria

• those with recent upper respiratory tract infections, evidence of bleeding disorders, serous otitis media, chronic tonsillitis
• those advised against undergoing adenoidectomy after consulting a phoniatrist
• patients with atrophic rhinitis those with nasal obstruction caused by other nasal or paranasal conditions such as inferior turbinate hypertrophy, Choanal atresia, deviated nasal septum, antrochoanal polyps, and other causes of nasal obstruction in children.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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245 participants in 2 patient groups

patients who underwent the adenoidectomy using suction diathermy

Active Comparator group

Description:

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.

Treatment:

Procedure: adenoidectomy by Suction diathermy

patients who underwent the adenoidectomy using coblation

Experimental group

Description:

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.

Treatment:

Procedure: adenoidectomy using coblatioion