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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Adenoid Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The patients are not going to be given the detail about the days, so that they would not know which group they would be in. Care provider and investigator would not know which patient is going to be operated on which day. Outcome assessor would not know which patient received which treatment while examining for the long term results.

Study Groups

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Conventional Curettage Adenoidectomy

Adenoidectomy with Beckmann Adenoid Curette

Group Type ACTIVE_COMPARATOR

Conventional cold curettage adenoidectomy

Intervention Type PROCEDURE

Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.

Curettage Adenoidectomy With Transoral Endoscopic Ablation

Transoral endoscopic adenoidectomy with Coblator 2 system

Group Type EXPERIMENTAL

Curettage adenoidectomy with transoral endoscopic ablation

Intervention Type PROCEDURE

Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue.

Interventions

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Curettage adenoidectomy with transoral endoscopic ablation

Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue.

Intervention Type PROCEDURE

Conventional cold curettage adenoidectomy

Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.

Intervention Type PROCEDURE

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No