CompletedNot Applicable

Oxidized Regenerated Cellulose and Voice Quality After Total Thyroidectomy

Turkey (Türkiye)30 participantsStarted 2014-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Jitter Percentage at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Shimmer Percentage at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Normalized Noise Energy at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Harmonics-to-Noise Ratio at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Maximum Phonation Time at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in the s/z Ratio at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Trial details

NCT IDNCT07681557

SponsorAnkara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07-31

View on ClinicalTrials.gov More Thyroid Diseases trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Change From Baseline in Jitter Percentage at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Shimmer Percentage at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Normalized Noise Energy at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Harmonics-to-Noise Ratio at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in Maximum Phonation Time at Postoperative Day 21

Timeframe: Baseline to postoperative day 21

Change From Baseline in the s/z Ratio at Postoperative Day 21

Timeframe: Baseline to postoperative day 21