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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Adenoid Hypertrophy
• Intervention / Treatment: Procedure: Conventional cold curettage adenoidectomy; Procedure: Curettage adenoidectomy with transoral endoscopic ablation

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University, Istanbul Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Curettage Adenoidectomy; Adenoidectomy with Beckmann Adenoid Curette	Procedure: Conventional cold curettage adenoidectomy; Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.
Experimental: Curettage Adenoidectomy With Transoral Endoscopic Ablation; Transoral endoscopic adenoidectomy with Coblator 2 system	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Beldan Polat, Istanbul University

Publications and helpful links

General Publications

• Bidaye R, Vaid N, Desarda K. Comparative analysis of conventional cold curettage versus endoscopic assisted coblation adenoidectomy. J Laryngol Otol. 2019 Apr;133(4):294-299. doi: 10.1017/S0022215119000227. Epub 2019 Mar 19.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: adenoidectomy; curettage; adenoids
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: 2019/1553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes