Coblation Versus Suction Diathermy in Pediatric Adenoidectomy

Not Applicable

Completed

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

• Registration Number: NCT06841432
• Lead Sponsor: Al-Azhar University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operative duration	During the procedure	The procedure, from the initial insertion of the Bowel-Davis mouth gag to the complete removal of the adenoid and the gag, was timed in minutes.
Intraopertive blood loss	during the procedures	Boezaart surgical field grading scale was used to evaluate the intraoperative bleeding
Postopertaive Pain	Patients reported their pain levels every day before taking any pain medication during the 7 days after their surgery	The Wong-Baker Pain Scale consists of 6 faces depicting different levels of pain. Face 1 represents no pain, Face 2 indicates a little bit of hurt, Face 3 indicates a little more hurt, Face 4 indicates even more hurt, Face 5 indicates a whole lot of hurt, and Face 6 indicates the worst possible hurt, with pain scores ranging from 0 to 10. Both the children and their parents were informed about the purpose of the questionnaires and how to fill them out before the surgery

Secondary Outcome Measures

Name	Time	Method
Development of bad breath	from the end of operation till 2 weeks post operation	frequency of Children who presented with bad breath
recovery time	three months post opertaive	time which was talken for the patients to resume their normal social routines
secondary bleeding	up to one month surgery	frequency of Children who presented with bleeding that occurred after 24 hrs of operation
Pre- and post-adenoid size grading	preintervention (one day before opertaion ) and postintervention (up to three months)	The Parikh grading system (1-4) is used to assess the extent of adenoid tissue contact with surrounding structures: Grade 1 - adenoid tissue not in contact, Grade 2 - adenoid tissue in contact with Eustachian tube cushions, Grade 3 - adenoid tissue in contact with vomer, Grade 4 - adenoid tissue in contact with soft palate

Trial Locations

Locations (1)

Alazhar university Hopital in Assiut; 🇪🇬 Assiut, Egypt