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NCT Number: NCT07681557

Oxidized Regenerated Cellulose and Voice Quality After Total Thyroidectomy

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.

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Key information

Conditions

Thyroid Diseases Endocrine System Diseases Postoperative Voice Change

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University School of Medicine, Ibn-i Sina Hospital

Ankara, 06100, Turkey (Türkiye)

About this study

This was a prospective, single-center, randomized, two-arm, parallel-group controlled trial involving patients undergoing bilateral total thyroidectomy for benign or malignant thyroid disease.

Before surgery, all participants underwent videolaryngostroboscopic examination to document normal vocal cord mobility and recurrent laryngeal nerve function. Objective acoustic voice analysis was also performed before surgery.

All operations were performed by the same experienced endocrine surgeon through a standard Kocher collar incision. Both recurrent laryngeal nerves and the parathyroid glands were routinely identified and preserved. Conventional hemostasis was achieved using bipolar cautery while avoiding thermal injury to the recurrent laryngeal nerves.

Immediately before completion of surgery, participants were randomized in a 1:1 ratio using a simple card-drawing method performed by an assistant. In the experimental group, a 1 × 2 cm piece of oxidized regenerated cellulose was placed bilaterally over the recurrent laryngeal nerves within the thyroid bed. In the control group, surgery was completed after conventional hemostasis without placement of oxidized regenerated cellulose.

Objective acoustic voice analysis was repeated on postoperative day 21 using 15-second voice recordings analyzed with Dr. Speech Real Analysis software. The assessed acoustic outcomes included jitter, shimmer, normalized noise energy, harmonics-to-noise ratio, maximum phonation time, and the s/z ratio.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxidized Regenerated Cellulose

Device

A sterile, absorbable topical hemostatic material. A 1 × 2 cm piece was placed bilaterally over the recurrent laryngeal nerves within the thyroid bed after conventional hemostasis had been achieved.

Other names: Surgicel

Primary outcomes

  1. Change From Baseline in Jitter Percentage at Postoperative Day 21

    Time frame: Baseline to postoperative day 21

    Jitter was calculated from a 15-second voice recording using Dr. Speech Real Analysis software and reported as a percentage. Change was calculated as the postoperative value minus the preoperative value.

  2. Change From Baseline in Shimmer Percentage at Postoperative Day 21

    Time frame: Baseline to postoperative day 21

    Shimmer was calculated from a 15-second voice recording using Dr. Speech Real Analysis software and reported as a percentage. Change was calculated as the postoperative value minus the preoperative value.

  3. Change From Baseline in Normalized Noise Energy at Postoperative Day 21

    Time frame: Baseline to postoperative day 21

    Normalized noise energy was measured using Dr. Speech Real Analysis software and reported in decibels. Change was calculated as the postoperative value minus the preoperative value.

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

    Time frame: Baseline to postoperative day 21

    The harmonics-to-noise ratio was measured using Dr. Speech Real Analysis software and reported in decibels. Change was calculated as the postoperative value minus the preoperative value.

  5. Change From Baseline in Maximum Phonation Time at Postoperative Day 21

    Time frame: Baseline to postoperative day 21

    Maximum phonation time was measured in seconds during acoustic voice assessment. Change was calculated as the postoperative value minus the preoperative value.

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

    Time frame: Baseline to postoperative day 21

    The s/z ratio was calculated by dividing the maximum duration of sustained /s/ phonation by the maximum duration of sustained /z/ phonation. Change was calculated as the postoperative value minus the preoperative value.

Secondary outcomes

  1. Number of Participants With Postoperative Surgical Complications

    Time frame: From surgery through postoperative day 21

    Postoperative complications included vocal cord paralysis, postoperative bleeding, wound infection, wound dehiscence, seroma, hypocalcemia, hypoparathyroidism, and local adverse reactions considered potentially related to oxidized regenerated cellulose.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Effect of Oxidized Regenerated Cellulose on Voice Quality After Total Thyroidectomy: A Prospective Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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