Tokyo, Oct. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059279) titled 'A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea' on Oct. 10.

Study Type: Observational

Primary Sponsor: Institute - Jichi medical university

Condition: Condition - Pediatric Obstructive Sleep Apnea Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In this study, we aim to compare intracapsular tonsillectomy with Coblator (CIT), intracapsular tonsillectomy with microdebrider (PIT), and conventional extracapsular tonsillectomy for pediatric obstructive sleep apnea (OSA),with the following objectives; 1.Comparison of Postoperative Pain We will compare pain scores from the day after surgery through postoperative day 5 across surgical techniques to evaluate the degree of pain reduction. Additionally, the amount of analgesic use will be assessed to examine postoperative recovery. 2.Verification of Safety We will record adverse events such as postoperative hemorrhage and tissue damage to evaluate differences in safety between procedures. 3.Assessment of Surgical Factors We will investigate whether differences in surgical time or the surgeon's years of experience influence the outcomes depending on the surgical method. 4.Evaluation of Postoperative Course After discharge, patients'apnea status will be assessed using questionnaires. Through these analyses, we aim to establish criteria for selecting the optimal tonsillectomy technique for pediatric OSA, and to provide evidence that will contribute to the development of clinical guidelines and the standardization of medical practice in Japan. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 3 years-old = Gender - Male and Female Key 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 Key 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 Target Size - 180

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067809

Disclaimer: Curated by HT Syndication.