Adenoidal HypertrophyNCT06169384
Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms
A study testing Endoscopic adenoidectomy in people with Adenoidal Hypertrophy, run by Assiut University at 1 site in Egypt.
Trial summary
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Adenoidal Hypertrophy
- What is being tested?
- Endoscopic adenoidectomy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jun 2024
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- .all patients with adenoid hypertrophy causing airway obstruction.
Who cannot join
- 1. Chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
- 2 . Systemic medical problems interfering with surgery.
- 3 . Refusal of parents to participate.
- 4. Craniofacial abnormalities.
- 5. Down syndrome.
Trial locations and contacts
1 site in 1 country.
Mohamed M Roshdy contact
About this study
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
- Conditions
- Adenoidal Hypertrophy
- Being tested
- Endoscopic adenoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic adenoidectomyDevice
Subjects will be randomly assigned into two groups (30 patient each group): Group A will undergo endoscopic partial adenoidectomy using the 70◦ rigid endoscope trans-orally and shaver (microdebrider) ,by removing the upper (choanal) part only with leaving the lower part of the adenoid .(2) Group B will undergo total adenoidectomy ,by removing all the adenoid lymphoid tissue .
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic total adenoidectomy | Active comparator | Not described Receives: Device: Endoscopic adenoidectomy |
| Endoscopic partial adenoidectomy | Active comparator | Not described Receives: Device: Endoscopic adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
- Relief of nasal obstruction while preserving the function of velopharyngeal valve and assessment of the recurrence rate.
Measured: 1 to 2 years .
Incidence of recurrence using fibro-optic evaluation
Relief of nasal obstruction of posterior nasal chona using fibro-optic evaluation and assessment of recurrence rate using also questionnaires sheets to all parents.
Measured: 1 to 2 years .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Sep 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adenoidal HypertrophyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Mohamed Ragheb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169384
- Sponsor's protocol ID
- Endoscopic adenoidectomy
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Jervis-Bardy, J.; Department of Otolaryngology, Arkansas Children's Hospital, cLittle Rock, AR, United States. Journal of Craniofacial SurgeryVolume 30, Issue 5, Pages E454 - E4602019.
1. Kummer AW, Lee L. Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 27:271-281
Saunders NC, Hartley BE, Sell D, Sommerlad B. Velopharyngeal insufficiency following adenoidectomy. Clin Otolaryngol Allied Sci. 2004 Dec;29(6):686-8. doi: 10.1111/j.1365-2273.2004.00870.x.
PubMed 15533160
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms
- ClinicalTrials.gov ID
- NCT06169384
- Acronym / sponsor ID
- Endoscopic adenoidectomy
- Conditions
- Adenoidal Hypertrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Dec 2023 (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.
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic total adenoidectomy | Active comparator | Device: Endoscopic adenoidectomy |
| Endoscopic partial adenoidectomy | Active comparator | Device: Endoscopic adenoidectomy |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- .all patients with adenoid hypertrophy causing airway obstruction.
Key exclusion criteria (5 listed)
- 1. Chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
- 2 . Systemic medical problems interfering with surgery.
- 3 . Refusal of parents to participate.
- 4. Craniofacial abnormalities.
- 5. Down syndrome.
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 |
|---|---|---|
| Endoscopic adenoidectomySubjects will be randomly assigned into two groups (30 patient each group): Group A will undergo endoscopic partial adenoidectomy using the 70◦ rigid endoscope trans-orally and shaver (microdebrider) ,by removing the upper (choanal) part only with leaving the lower part of the adenoid .(2) Group B will undergo total adenoidectomy ,by removing all the adenoid lymphoid tissue . | Device | Endoscopic partial adenoidectomy, Endoscopic total adenoidectomy |
Primary outcome
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
Time frame: 1 to 2 years .
1. Relief of nasal obstruction while preserving the function of velopharyngeal valve and assessment of the recurrence rate.
Incidence of recurrence using fibro-optic evaluation
Time frame: 1 to 2 years .
Relief of nasal obstruction of posterior nasal chona using fibro-optic evaluation and assessment of recurrence rate using also questionnaires sheets to all parents.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Background1. Jervis-Bardy, J.; Department of Otolaryngology, Arkansas Children's Hospital, cLittle Rock, AR, United States. Journal of Craniofacial SurgeryVolume 30, Issue 5, Pages E454 - E4602019.
- Background1. Kummer AW, Lee L. Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 27:271-281
- Background: PubMed 15533160Saunders NC, Hartley BE, Sell D, Sommerlad B. Velopharyngeal insufficiency following adenoidectomy. Clin Otolaryngol Allied Sci. 2004 Dec;29(6):686-8. doi: 10.1111/j.1365-2273.2004.00870.x.
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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.
Mohamed M Roshdy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic adenoidectomy in people with Adenoidal Hypertrophy, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M Ragheb (01010058868, Mohammedragheb95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction. (time frame: 1 to 2 years .). The study lists 2 primary outcomes in all. 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 NCT06169384, which also lists 3 linked publications.
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 13 Dec 2023.