CompletedNot Applicable

Tonsillectomy and Expansion Sphincter Pharyngoplasty Operations

Turkey (Türkiye)53 participantsStarted 2022-01-01

Plain-language summary

Background: To compare the efficacy of tonsillectomy and expansion sphincter pharyngoplasty (ESP) in the surgical treatment of obstructive sleep apnea (OSA). Methods: Patients with Friedman grade III-IV tonsil hypertrophy and OSA diagnosed with polysomnography were separated into two groups according to the surgery performed, as the classic tonsillectomy group (Group 1) and the ESP group (Group 2). The primary endpoint of the study was to determine the Apnea-Hypopnea Index (AHI) value. The preoperative and postoperative AHI scores and the decreases in these scores were noted. The change in AHI was calculated as a percentage (preoperative AHI - postoperative AHI/ preoperative AHI x 100) and the two groups were compared. An AHI value of \<10 events/hour was accepted as cure.

Who can participate

Age range27 Years – 64 Years

SexALL

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

Inclusion Criteria: * patients aged \>27 years * Apnea-Hypopnea Index (AHI) value of ≥10. Exclusion Criteria: * absent preoperative and/or postoperative PSG * craniofacial anomaly such as evident retrognathia * severe cardiac, respiratory, or neurological disease * an evident obstruction at the tongue base level in the endoscopic examination

What they're measuring

Apnea-Hypopnea Index (AHI)

Timeframe: 1 hour

Trial details

NCT IDNCT06119841

SponsorSaglik Bilimleri Universitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-28

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