- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494370
Adenoidectomy: Correlation Between Individual Factors, Surgical Technique, and Residual Adenoids
Adenoidectomy is the most commonly performed otolaryngological surgical procedure in children. The removal of adenoid lymphoid tissue is intended to clear the nasopharynx and restore the patency of the nasal airways. In most cases, adenoidectomy leads to an improvement in symptoms and quality of life. However, in some patients, symptoms recur with the presence of lymphoid tissue obstructing the nasopharynx. In these cases, a surgical revision is often necessary.
The traditional surgical technique is performed using an adenoid curette or Shambaugh adenotome without direct visualization of the surgical field. Among the known limitations of this surgery is the possibility of leaving intraoperative adenoid residues. In the literature, regarding the detection of adenoid vegetations in patients who have already undergone adenoidectomy, the term "regrowth" of lymphoid tissue is often used; however, this term is correctly applied only when there is certainty of complete adenoid excision during the procedure. In the absence of this certainty, it would therefore be more accurate to speak of persistence or recurrence of adenoid hypertrophy after adenoidectomy. However, this phenomenon is poorly understood due to the scarcity of information in the literature regarding the incidence, associated factors, and etiology of this clinical entity. In particular, there is still debate over whether the recurrence of symptoms following the detection of nasopharyngeal lymphoid tissue is due to incomplete surgical resection, or whether individual factors may coexist and contribute to the recurrence of adenoid lymphoid tissue. To date, the scientific literature has focused almost exclusively on intraoperative variables independent of the patient. The aim of this study is to evaluate whether there are patient-specific factors at the time of surgery-such as sex, age, weight, height, and soft palate length-that may influence the surgical efficacy of the traditional technique in terms of complete removal of adenoid lymphoid tissue.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Lombardy
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Pavia, Lombardy, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo di Pavia
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Contact:
- Fabio Giuseppe Pagella, MD
- Phone Number: 0382 503740/0382 503702
- Email: f.pagella@smatteo.pv.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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assessment of the influence of anatomical factors on surgical outcomes
Time Frame: Up to 5 years
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To assess whether individual anatomical factors such as age, sex, weight, and height-and, in particular, variables related to oropharyngeal anatomy-may influence surgical efficacy in terms of the complete removal of adenoid lymphoid tissue.
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Up to 5 years
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P_57145
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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