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Completed
NCT07681557
Oxidized Regenerated Cellulose and Voice Quality After Total Thyroidectomy
Conditions: Thyroid Diseases, Postoperative Voice Change
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Ankara University
Location: Ankara University School of Medicine, Ibn-i Sina Hospital Ankara Ankara
Summary
This randomized controlled trial evaluated whether placement of oxidized regenerated cellulose (ORC) over the recurrent laryngeal nerves during total thyroidectomy affects early postoperative voice quality. Patients undergoing bilateral total thyroidectomy for benign or malignant thyroid disease were assigned in a 1:1 ratio to bilateral placement of ORC within the thyroid bed or to conventional hemostasis without ORC.
All participants underwent preoperative videolaryngostroboscopic examination and objective acoustic voice analysis. Acoustic assessment was repeated on postoperative day 21. The study evaluated changes in jitter, shimmer, normalized noise energy, harmonics-to-noise ratio, maximum phonation time, and the s/z ratio. Postoperative complications and adverse events potentially related to ORC were also recorded.
Eligibility Criteria
Inclusion Criteria
* Patients scheduled to undergo bilateral total thyroidectomy for benign or malignant thyroid disease.
* Written informed consent for participation.
* Normal preoperative vocal cord mobility and recurrent laryngeal nerve function documented by videolaryngostroboscopic examination.
Exclusion Criteria
* Previous thyroid surgery.
* Previous parathyroid surgery.
* Previous vocal cord surgery.
* Previous laryngeal surgery.
* Preoperative vocal cord paralysis.
* Preoperative vocal cord polyp.
* Any other preoperative laryngeal pathology considered likely to interfere with acoustic voice analysis.
Source: ClinicalTrials.gov (NCT07681557). StuddyBuddy aggregates publicly available trial information.