NCT07494370

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Aug 2020Aug 2026

Study Start

First participant enrolled

August 20, 2020

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

March 20, 2026

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of the influence of anatomical factors on surgical outcomes

    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.

    Up to 5 years

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy

You may qualify if:

  • Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 27, 2026

Study Start

August 20, 2020

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations