CompletedNot Applicable

Evaluation of the Functional Impact of Adenotonsilectomy

Portugal78 participantsStarted 2020-08-20

Plain-language summary

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

Who can participate

Age range

4 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 4-14 years; * Patients with surgical indication for any combination of: * tonsillectomy * adenoidectomy * turbinoplasty * myringotomy; * naive children (not submitted to previous ENT surgery); * signature of informed consent by the parent entity. Exclusion Criteria: * Age under 4 years and over 14 years; * surgery: myringotomy+TT placement exclusively; * associated co-morbidities: * asthma/other obstructive lung diseases * congenital facial or thoracic dysmorphism * neurological disease with cognitive impairment * cardiopulmonary disease * patients without surgical indication * other causes of nasal obstruction (severe septum deviation or polyps).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Forced expiratory volume in the first second (FEV 1)

Timeframe: 3 months after surgery

Forced vital capacity (FVC)

Timeframe: 3 months after surgery

Peak expiratory flow (PEF)

Timeframe: 3 months after surgery

forced expiratory flow rate at 25% (F25)

Timeframe: 3 months after surgery

forced expiratory flow rate at 75% (F75)

Timeframe: 3 months after surgery

forced expiratory flow between 25 and 75% of the pulmonary volume (FEF25-75%).

Timeframe: 3 months after surgery

Trial details

NCT IDNCT05532228

SponsorInstituto de Ciências Biomédicas Abel Salazar

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Apnea, Obstructive trials

Who can participate

Age range

4 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Forced expiratory volume in the first second (FEV 1)

Timeframe: 3 months after surgery

Forced vital capacity (FVC)

Timeframe: 3 months after surgery

Peak expiratory flow (PEF)

Timeframe: 3 months after surgery

forced expiratory flow rate at 25% (F25)

Timeframe: 3 months after surgery

forced expiratory flow rate at 75% (F75)

Timeframe: 3 months after surgery

forced expiratory flow between 25 and 75% of the pulmonary volume (FEF25-75%).

Timeframe: 3 months after surgery