Conventional Curettage Adenoidectomy vs Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children

Istanbul University

Status: Withdrawn

Conditions: Adenoid Hypertrophy

Treatments: Procedure: Curettage adenoidectomy with transoral endoscopic ablation; Procedure: Conventional cold curettage adenoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04302337

2019/1553

Details and patient eligibility

About

This prospective study is designed to compare short and long term results of conventional cold curettage adenoidectomy in children performed without doing any endoscopic or mirror examination before ending the operation versus when combined with transoral endoscopic residue ablation using a wand.

Full description

Residual or recurrent adenoid tissue that causes persistence or recurrence of symptoms is observed frequently after conventional cold curettage adenoidectomy. New techniques to better visualize or excise the tissue in order to prevent this situation are being developed. This study aims to compare transoral endoscopic controlled adenoidectomy with conventional blind curettage adenoidectomy in terms of recurrent adenoid hypertrophy. Although there are other studies comparing the results of the two techniques in terms of early residual adenoid tissue and bleeding, no studies comparing the long term results were found in literature. This prospective study is planned to focus on both early examination of residual tissue and long term recurrence.

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients within 3-12 years old
• Patients undergoing tonsillectomy and adenoidectomy for obstructive sleep disorder
• Patients undergoing adenoidectomy and ventilation tube insertion for chronic otitis media with effusion (OME)
• Patients undergoing adenoidectomy alone for obstructive sleep disorder
• Patients undergoing adenoidectomy alone for chronic OME
• Patients undergoing adenoidectomy alone for chronic sinusitis

Exclusion criteria

• Patients not between 3-12 years old
• Patients with craniofacial anomalies
• Revision adenoidectomy
• Proven significant comorbidities
• Systemic diseases
• Bleeding diathesis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Conventional Curettage Adenoidectomy

Active Comparator group

Description:

Adenoidectomy with Beckmann Adenoid Curette

Treatment:

Procedure: Conventional cold curettage adenoidectomy

Curettage Adenoidectomy With Transoral Endoscopic Ablation

Experimental group

Description:

Transoral endoscopic adenoidectomy with Coblator 2 system

Treatment:

Procedure: Curettage adenoidectomy with transoral endoscopic ablation