Oxidized Regenerated Cellulose and Voice Quality After Total Thyroidectomy

June 26, 2026 updated by: Volkan Genc, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06100
        • Ankara University School of Medicine, Ibn-i Sina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxidized Regenerated Cellulose
Participants underwent standard bilateral total thyroidectomy and conventional bipolar hemostasis. A 1 × 2 cm piece of oxidized regenerated cellulose was placed bilaterally over the recurrent laryngeal nerves within the thyroid bed immediately before completion of the operation.
Device: Oxidized Regenerated Cellulose
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
No Intervention: Conventional Hemostasis Without ORC
Participants underwent the same standard bilateral total thyroidectomy and conventional bipolar hemostasis. No oxidized regenerated cellulose was placed within the thyroid bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to postoperative day 21
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.
Baseline to postoperative day 21
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.
Baseline to postoperative day 21
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.
Baseline to postoperative day 21
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.
Baseline to postoperative day 21
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.
Baseline to postoperative day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From surgery through postoperative day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

July 31, 2014

Study Completion (Actual)

August 31, 2014

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-598-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the original informed consent did not include permission for external data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Diseases

Clinical Trials on Oxidized Regenerated Cellulose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe