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

Adenoid Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04302337
• Other study ID #: 2019/1553
• Status: Withdrawn
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 2021

Study information

• Verified date: November 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoid Hypertrophy
• Hypertrophy

Intervention

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.
• Conventional cold curettage adenoidectomy
Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual adenoid tissue evaluation with Parikh grade	Endoscopic examination of adenoid tissue postoperatively	1 year after surgery
Secondary	Bleeding	The frequency of postoperative bleeding complication	Up to 2 weeks after surgery
Secondary	Otitis media with effusion	Persistency and recurrence of OME after adenoidectomy	Up to 1 year after surgery