Adenoid HypertrophyNCT04302337
Conventional Curettage Adenoidectomy vs Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children
A study testing Curettage adenoidectomy with transoral endoscopic ablation and Conventional cold curettage adenoidectomy in people with Adenoid Hypertrophy, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Adenoid Hypertrophy
- What is being tested?
- Curettage adenoidectomy with transoral endoscopic ablation and Conventional cold curettage adenoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients not between 3-12 years old
- Patients with craniofacial anomalies
- Revision adenoidectomy
- Proven significant comorbidities
- Systemic diseases
- Bleeding diathesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul
About this study
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
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.
Read the 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.
- Conditions
- Adenoid Hypertrophy
- Being tested
- Curettage adenoidectomy with transoral endoscopic ablation, Conventional cold curettage adenoidectomy
- Keywords
- adenoidectomy, adenoids, curettage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curettage adenoidectomy with transoral endoscopic ablationProcedure or surgery
Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue.
Conventional cold curettage adenoidectomyProcedure or surgery
Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Curettage Adenoidectomy | Active comparator | Adenoidectomy with Beckmann Adenoid Curette Receives: Procedure: Conventional cold curettage adenoidectomy |
| Curettage Adenoidectomy With Transoral Endoscopic Ablation | Experimental | Transoral endoscopic adenoidectomy with Coblator 2 system Receives: Procedure: Curettage adenoidectomy with transoral endoscopic ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual adenoid tissue evaluation with Parikh grade
Endoscopic examination of adenoid tissue postoperatively
Measured: 1 year after surgery
Secondary outcomes (2)
Bleeding
The frequency of postoperative bleeding complication
Measured: Up to 2 weeks after surgery
Otitis media with effusion
Persistency and recurrence of OME after adenoidectomy
Measured: Up to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start15 Oct 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: technical and funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoid HypertrophyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BELDAN POLAT, Istanbul University
- Investigators
- Beldan Polat, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302337
- Sponsor's protocol ID
- 2019/1553
- Status last verified
- Nov 2022
- First submitted
- 23 Feb 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30885281
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04302337
- Acronym / sponsor ID
- 2019/1553
- Conditions
- Adenoid Hypertrophy
- Keywords
- adenoidectomy, adenoids, curettage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: technical and funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Curettage Adenoidectomy | Active comparator | Procedure: Conventional cold curettage adenoidectomyAdenoidectomy with Beckmann Adenoid Curette |
| Curettage Adenoidectomy With Transoral Endoscopic Ablation | Experimental | Procedure: Curettage adenoidectomy with transoral endoscopic ablationTransoral endoscopic adenoidectomy with Coblator 2 system |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Patients not between 3-12 years old
- Patients with craniofacial anomalies
- Revision adenoidectomy
- Proven significant comorbidities
- Systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curettage adenoidectomy with transoral endoscopic ablationTransoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue. | Procedure or surgery | Curettage Adenoidectomy With Transoral Endoscopic Ablation |
| Conventional cold curettage adenoidectomyConventional cold curettage adenoidectomy without endoscopic examination for residual tissue. | Procedure or surgery | Conventional Curettage Adenoidectomy |
Primary outcome
Residual adenoid tissue evaluation with Parikh grade
Time frame: 1 year after surgery
Endoscopic examination of adenoid tissue postoperatively
2 secondary outcomes
Bleeding
Time frame: Up to 2 weeks after surgery
Otitis media with effusion
Time frame: Up to 1 year after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Results publication: PubMed 30885281Bidaye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beldan Polat principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curettage adenoidectomy with transoral endoscopic ablation and Conventional cold curettage adenoidectomy in people with Adenoid Hypertrophy, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual adenoid tissue evaluation with Parikh grade (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.