Clinical trial NCT04302337: Conventional Curettage Adenoidectomy vs Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adenoid Hypertrophy
Keywords: adenoidectomy
adenoids
curettage
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Residual adenoid tissue evaluation with Parikh grade
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Bleeding
timeFrame: Up to 2 weeks after surgery
measure: Otitis media with effusion
timeFrame: Up to 1 year after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul University
name: Beldan Polat
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.