A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea

A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea - A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059279

Enrollment

180

Registered

2025-10-10

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obstructive Sleep Apnea

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children diagnosed with obstructive sleep apnea (OSA) Scheduled to undergo surgery with either CIT, PIT, or the conventional method Cases in which postoperative follow-up is possible Cases for which informed consent can be obtained from the guardian

Exclusion criteria

Exclusion criteria: Cases in which surgery is performed at another institution Cases not undergoing adenoidectomy Cases participating in other interventional studies during the study period Children with severe motor and intellectual disabilities Children considered to be at high risk of bleeding like hematologic diseases or taking antiplatelet agents Children with concomitant conditions related to apnea, such as craniofacial malformations, pharyngeal stenosis, or mixed-type sleep apnea

Design outcomes

Primary

Measure	Time frame
Postoperative pain scores (daily assessment on postoperative days 1 to 5 using the FLACC scale)	—

Countries

Japan

Contacts

Public ContactMASAO NODA

Jichi medical university Otolaryngology

doforanabdosuc@gmail.com0285442111

Outcome results