TonsillectomyNCT07494370
Adenoidectomy: Correlation Between Individual Factors, Surgical Technique, and Residual Adenoids
An observational study of Tonsillectomy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Tonsillectomy
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Aug 2020to 20 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- Child, Adult
Study population: Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy
Who may be able to join
- Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
Fabio Giuseppe Pagella, MD, 0382 503740/0382 503702, f.pagella@smatteo.pv.it
About this study
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.
- Conditions
- Tonsillectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start20 Aug 2020
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Giuseppe Pagella, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494370
- Sponsor's protocol ID
- P_57145
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoidectomy: Correlation Between Individual Factors, Surgical Technique, and Residual Adenoids
- ClinicalTrials.gov ID
- NCT07494370
- Acronym / sponsor ID
- P_57145
- Conditions
- Tonsillectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 27 Mar 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy
Key inclusion criteria (1 listed)
- Pediatric patients evaluated at the upper airway endoscopy clinic who are candidates for adenoidectomy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assessment of the influence of anatomical factors on surgical outcomes
Time frame: Up to 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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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.
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillectomy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 0 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the influence of anatomical factors on surgical outcomes (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.