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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Short and Long-term Results of Conventional Curettage Adenoidectomy Without Endoscopy Assistance Versus Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children

Conditions
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Adenoid Hypertrophy

Intervention / Treatment
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* Procedure: Curettage adenoidectomy with transoral endoscopic ablation
* Procedure: Conventional cold curettage adenoidectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive conventional cold curettage adenoidectomy treatment while the other group will receive curettage adenoidectomy with transoral endoscopic residue ablation treatment. The patients operated on Tuesdays and Fridays will receive the first treatment while on Mondays and Thursdays the second treatment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Curettage Adenoidectomy<br>Adenoidectomy with Beckmann Adenoid Curette | Procedure: Conventional cold curettage adenoidectomy<br>* Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.<br>|
| Experimental: Curettage Adenoidectomy With Transoral Endoscopic Ablation<br>Transoral endoscopic adenoidectomy with Coblator 2 system | Procedure: Curettage adenoidectomy with transoral endoscopic ablation<br>* Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual adenoid tissue evaluation with Parikh grade | Endoscopic examination of adenoid tissue postoperatively | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | The frequency of postoperative bleeding complication | Up to 2 weeks after surgery | 
| Otitis media with effusion | Persistency and recurrence of OME after adenoidectomy | Up to 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoidectomy, adenoids, curettage