Conventional Curettage Adenoidectomy vs Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children
Primary Purpose
Adenoid Hypertrophy
Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Curettage adenoidectomy with transoral endoscopic ablation
Conventional cold curettage adenoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Adenoid Hypertrophy focused on measuring adenoidectomy, adenoids, curettage
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
Sites / Locations
- Istanbul University, Istanbul Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Curettage Adenoidectomy
Curettage Adenoidectomy With Transoral Endoscopic Ablation
Arm Description
Adenoidectomy with Beckmann Adenoid Curette
Transoral endoscopic adenoidectomy with Coblator 2 system
Outcomes
Primary Outcome Measures
Residual adenoid tissue evaluation with Parikh grade
Endoscopic examination of adenoid tissue postoperatively
Secondary Outcome Measures
Bleeding
The frequency of postoperative bleeding complication
Otitis media with effusion
Persistency and recurrence of OME after adenoidectomy
Full Information
NCT ID
NCT04302337
First Posted
February 23, 2020
Last Updated
November 6, 2022
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT04302337
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
technical and funding issues
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Hypertrophy
Keywords
adenoidectomy, adenoids, curettage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Curettage Adenoidectomy
Arm Type
Active Comparator
Arm Description
Adenoidectomy with Beckmann Adenoid Curette
Arm Title
Curettage Adenoidectomy With Transoral Endoscopic Ablation
Arm Type
Experimental
Arm Description
Transoral endoscopic adenoidectomy with Coblator 2 system
Intervention Type
Procedure
Intervention Name(s)
Curettage adenoidectomy with transoral endoscopic ablation
Intervention Description
Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue.
Intervention Type
Procedure
Intervention Name(s)
Conventional cold curettage adenoidectomy
Intervention Description
Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.
Primary Outcome Measure Information:
Title
Residual adenoid tissue evaluation with Parikh grade
Description
Endoscopic examination of adenoid tissue postoperatively
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Bleeding
Description
The frequency of postoperative bleeding complication
Time Frame
Up to 2 weeks after surgery
Title
Otitis media with effusion
Description
Persistency and recurrence of OME after adenoidectomy
Time Frame
Up to 1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beldan Polat
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30885281
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.
Results Reference
result
Learn more about this trial
Conventional Curettage Adenoidectomy vs Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children
We'll reach out to this number within 24 hrs