Thyroid DiseasesNCT07681557
Oxidized Regenerated Cellulose and Voice Quality After Total Thyroidectomy
A study testing Oxidized Regenerated Cellulose in people with Thyroid Diseases and Postoperative Voice Change, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Diseases, Postoperative Voice Change
- What is being tested?
- Oxidized Regenerated Cellulose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 31 Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine, Ibn-i Sina Hospital
Ankara, Ankara, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Diseases, Postoperative Voice Change
- Being tested
- Oxidized Regenerated Cellulose
- Keywords
- Oxidized regenerated cellulose, Surgicel, Total thyroidectomy, Recurrent laryngeal nerve, Voice quality, Acoustic voice analysis, Hemostasis, Postoperative voice change
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxidized Regenerated CelluloseDevice
Also called Surgicel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to postoperative day 21
Secondary outcomes (1)
Number of Participants With Postoperative Surgical Complications
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.
Measured: From surgery through postoperative day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jan 2014
- Primary completion31 Jul 2014
- Study completion31 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, two-arm, parallel-group randomized controlled trial with 1:1 allocation.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Genc, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681557
- Sponsor's protocol ID
- 13-598-14
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the original informed consent did not include permission for external data sharing.
Publications
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.
PubMed 40613790Dionigi 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.
PubMed 22297627Bergenfelz 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.
PubMed 18633639
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxidized Regenerated Cellulose on Voice Quality After Total Thyroidectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07681557
- Acronym / sponsor ID
- 13-598-14
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, two-arm, parallel-group randomized controlled trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Oxidized Regenerated Cellulose | Experimental | Device: Oxidized Regenerated CelluloseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Previous thyroid surgery.
- Previous parathyroid surgery.
- Previous vocal cord surgery.
- Previous laryngeal surgery.
- Preoperative vocal cord paralysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxidized Regenerated CelluloseAlso: SurgicelA 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. | Device | Oxidized Regenerated Cellulose |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Number of Participants With Postoperative Surgical Complications
Time frame: From surgery through postoperative day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 40613790Kuo 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.
- Background: PubMed 22297627Dionigi 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.
- Background: PubMed 18633639Bergenfelz 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the original informed consent did not include permission for external data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxidized Regenerated Cellulose in people with Thyroid Diseases and Postoperative Voice Change, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Jitter Percentage at Postoperative Day 21 (time frame: Baseline to postoperative day 21). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681557, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.