Oxidized Regenerated Cellulose and Voice Quality After Total Thyroidectomy

NCT07681557 | Completed

• 1 other identifier: 13-598-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Diseases; Postoperative Voice Change

Keywords

Oxidized regenerated cellulose; Surgicel; Total thyroidectomy; Recurrent laryngeal nerve; Voice quality; Acoustic voice analysis; Hemostasis; Postoperative voice change

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in Jitter Percentage at 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

  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

  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

  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

  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

  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 Outcomes (1)

• Number of Participants With Postoperative Surgical Complications

  From surgery through postoperative day 21

Study Arms (2)

Oxidized Regenerated Cellulose

EXPERIMENTAL

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

Conventional Hemostasis Without ORC

NO INTERVENTION

Participants underwent the same standard bilateral total thyroidectomy and conventional bipolar hemostasis. No oxidized regenerated cellulose was placed within the thyroid bed.

Interventions

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.

Also known as: Surgicel

Oxidized Regenerated Cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University School of Medicine, Ibn-i Sina Hospital

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• Kuo TC, Chen KY, Tsai YJ, Lin MT, Chang CH, Wu MH. Post-thyroid surgery adhesion prevention using oxidized regenerated cellulose and hyaluronic acid: prospective, single-blinded, randomized study. BJS Open. 2025 Jul 1;9(4):zraf079. doi: 10.1093/bjsopen/zraf079.

  PMID: 40613790 BACKGROUND

• Dionigi G, Bacuzzi A, Boni L, Rausei S, Rovera F, Dionigi R. Visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy: what about the costs? World J Surg. 2012 Apr;36(4):748-54. doi: 10.1007/s00268-012-1452-0.

  PMID: 22297627 BACKGROUND

• Bergenfelz A, Jansson S, Kristoffersson A, Martensson H, Reihner E, Wallin G, Lausen I. Complications to thyroid surgery: results as reported in a database from a multicenter audit comprising 3,660 patients. Langenbecks Arch Surg. 2008 Sep;393(5):667-73. doi: 10.1007/s00423-008-0366-7. Epub 2008 Jul 17.

  PMID: 18633639 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Surgery

Model Details: Single-center, two-arm, parallel-group randomized controlled trial with 1:1 allocation.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: January 1, 2014
• Primary Completion: July 31, 2014
• Study Completion: August 31, 2014
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)