Evaluation of the Functional Impact of Adenotonsilectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2022-02-01

Brief Summary

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Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

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Detailed Description

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Spirometric assessment of respiratory function before and after adenotonsillectomy surgery Study site at CHUPorto: Department of Otorhinolaryngology at CHUPorto, Portugal.

Study design: Institutional, observational, cohort, prospective. Classification of studies according to the law of clinical investigation (Dec. Law No. 21/2014): Clinical study without intervention. Main objective of the study: To collect a database referring to pediatric patients enrolled for surgery in an outpatient setting, in order to compare vital, spirometric and clinical parameters at two different times: pre and post surgical intervention.

Secondary objectives of the study: Based on validated indices, to assess the impact of surgical intervention on the child's respiratory and cardiovascular system. Participants: Patients undergoing surgery in the field of Pediatric Otorhinolaryngology at CHUPorto, a tertiary referral Hospital in Portugal.

Conditions

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Apnea, Obstructive Tonsillitis Tonsillar Hypertrophy Respiratory Function Impaired Infections ENT Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* 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).

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No