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Prospective Interventional Study in the Incidence of Adverse Events after Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin

Prospective Interventional Study in the Incidence of Adverse Events after Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin - Microlaryngeal Surgery without Discontinuation of Low-Dose Estrogen Progestin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056688
Enrollment
15
Registered
2025-04-01
Start date
2025-01-11
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

Vocal nodules Vocal polyps

Interventions

Performing microsurgical laryngeal procedures that are completed in a short period of time without discontinuation of low-dose pills in the 4 weeks prior to the perioperative period. This is an inter

Sponsors

International University of Health and Welfare
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Patients who visit Tokyo Voice Center on or after the date of approval and are scheduled to undergo microlaryngeal surgery under general anesthesia with a diagnosis of vocal nodule or vocal polyp (1) Patients taking low-dose pills who are scheduled to undergo microlaryngeal surgery under general anesthesia at Tokyo Voice Center on or after the date of approval (2) Patients who are able to obtain written consent to participate in the research of their own free will. (3) Patients who are between 18 and 50 years of age at the time of consent (4) Gender: Female

Exclusion criteria

Exclusion criteria: (1) Those with laryngeal diseases other than vocal nodules or vocal polyps (2) Patients with serious renal, cardiovascular, hematological (hereditary blood coagulation abnormalities), hepatic, and respiratory diseases (3) Patients with cancer and those undergoing anticancer drug treatment (4) Women who are pregnant or may become pregnant (5) Patients with cognitive impairment (6) Patients with a history of hypersensitivity to this drug (trafermin) (7) Patients who have participated in other clinical trials or clinical studies within 12 weeks prior to obtaining consent (8) Patients with a history of alcohol dependence or drug abuse (9) Undergraduate and graduate students of the University (10) Other patients deemed inappropriate for this study by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events

Countries

Japan

Contacts

Public ContactTomohiro Hasegawa

International University of Health and Welfare Tokyo Voice Center

t-hasegawa1@iuhw.ac.jp03-3402-5581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026