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

NCT04302337 | Withdrawn

• 1 other identifier: 2019/1553
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenoid Hypertrophy

Keywords

adenoidectomy; adenoids; curettage

Outcome Measures

Primary Outcomes (1)

• Residual adenoid tissue evaluation with Parikh grade

  Endoscopic examination of adenoid tissue postoperatively

  1 year after surgery

Secondary Outcomes (2)

• Bleeding

  Up to 2 weeks after surgery

• Otitis media with effusion

  Up to 1 year after surgery

Study Arms (2)

Conventional Curettage Adenoidectomy

ACTIVE COMPARATOR

Adenoidectomy with Beckmann Adenoid Curette

Procedure: Conventional cold curettage adenoidectomy

Curettage Adenoidectomy With Transoral Endoscopic Ablation

EXPERIMENTAL

Transoral endoscopic adenoidectomy with Coblator 2 system

Procedure: Curettage adenoidectomy with transoral endoscopic ablation

Interventions

Curettage adenoidectomy with transoral endoscopic ablation PROCEDURE

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

Curettage Adenoidectomy With Transoral Endoscopic Ablation

Conventional cold curettage adenoidectomy PROCEDURE

Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.

Conventional Curettage Adenoidectomy

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30885281 RESULT

Study Officials

• Beldan Polat

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: March 10, 2020
• Study Start: October 15, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)