ThyroidectomyNCT07532889
Comparing Medial and Lateral Dissection Approaches to the Recurrent Laryngeal Nerve During a Thyroidectomy
A study testing Approach to RLN during Thyroidectomy in people with Thyroidectomy, run by Oleksandr Butskiy.
Trial summary
The goal of this interventional study is to compare the effectiveness of two surgical approaches in identifying the recurrent laryngeal nerve (RLN) during thyroidectomy. The main questions it aims to answer are: How does each approach affect the length of hospital stay? How does each approach affect the number of… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- Approach to RLN during Thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing a total thyroidectomy or hemithyroidectomy under the care of the participating surgeons
Who cannot join
- Age less than 19 years old
- Previous thyroid or parathyroid surgery, substernal goiter, preoperative vocal cord palsy (VCP)
- Evidence of lateral or central neck lymph node metastases
- Intentional iatrogenic transection of the RLN due to tumor invasion
- Failure to assess real-time RLN functioning due to equipment issues with the IONM setup
- Presurgical dissection amplitude under 100uV
- Patient refusal to participate in the study
- Intraoperative decision to switch to a different approach to identifying the RLN
About this study
Official title: The Use of Continuous Nerve Monitoring to Compare Rates of Recurrent Laryngeal Nerve Injury Between Medial and Lateral Dissection Approaches to the Recurrent Laryngeal Nerve During a Thyroidectomy: A Prospective Randomized Controlled Trial
The goal of this interventional study is to compare the effectiveness of two surgical approaches in identifying the recurrent laryngeal nerve (RLN) during thyroidectomy. The main questions it aims to answer are:
How does each approach affect the length of hospital stay? How does each approach affect the number of adverse events that occur during surgery? How does each approach affect vocal cord function after surgery?
Read more
Researchers will compare the new medial approach to the standard lateral approach to evaluate its effectiveness.
Participants scheduled to undergo thyroidectomy surgery will be randomly assigned to one of these approaches after informed consent is obtained. Data will be collected during and after the surgery by a research assistant.
- Conditions
- Thyroidectomy
- Being tested
- Approach to RLN during Thyroidectomy
- Keywords
- Thyroidectomy, Medial Approach to Thyroidectomy, Lateral Approach to Thyroidectomy, Continuous Nerve Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach to RLN during ThyroidectomyProcedure or surgery
Medial vs Lateral Approach to RLN during thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Medial Approach | Experimental | Following the division of the isthmus, the edge on the resection side is grasped with Babcock forceps, placing it on lateral traction. The thyroid gland is then separated from the cricothyroid muscle and the trachea medially, leaving the berry's suspensory ligament adjacent to the first tracheal ring intact. The avascular space between the superior pole and the cricothyroid muscle is open. Finally, in the most critical step, the berry's ligament lateral to the first tracheal ring is placed on differential traction using two retractors - facilitating careful identification of the RLN as it courses under the superior edge of the berry's ligament - entering the larynx beneath the cricopharyngeus muscle. The RLN is identified at its most distal and consistent location as it enters the larynx. Receives: Procedure: Approach to RLN during Thyroidectomy |
| Lateral Approach | Active comparator | In the lateral approach group, the superior thyroid pedicle is mobilized and ligated, followed by medial rotation of the thyroid gland with division of the middle thyroid vein. Then, the RLN is identified in between the tubercle of Zuckerkandl and the cricothyroid joint. Berry's suspensory ligament is then divided. The thyroid lobe will then be completely dissected from the trachea as the final step in lobectomy. Receives: Procedure: Approach to RLN during Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative injury to the RLN
- LOS - as defined by a decline of amplitude to <100uV as measured by CIONM
- Combined adverse events - an event wherein both 50% reduction in EMG amplitude and 10% latency are observed on CIONM
Measured: Intraoperatively
Temporary vocal cord palsy as defined endoscopically
Measured: 2 weeks postoperatively
Secondary outcomes (8)
Hypoparathyroidism
- Temporary hypocalcemia - ionized calcium <1.0 mmol/L on post operative day 1 OR any requirement for calcium AND vitamin D supplementation for 6 months or less post surgery
- Permanent hypocalcemia - any hypocalcemia requiring calcium AND vitamin D supplementation for over 6 months post surgery
Measured: 6 months postoperatively
Postoperative hematoma requiring evacuation in the operating room
Yes/No
Measured: Immediately following surgery
Postoperative hematoma not requiring evacuation in the operating room
Yes/No
Measured: Immediately following surgery
Skin to skin operative time (minutes)
Measured: Intraoperatively
Number of instances that the patient was randomized to a specific approach to identifying the RLN, but a different approach was taken by the surgeon
Reasons for taking a different approach will be documented as well
Measured: Intraoperatively
Permanent vocal cord palsy as defined endoscopically
Measured: 6 months postoperatively
Patient scar satisfaction score measured with Patient Scar Assessment Questionnaire (PSAQ)
Each of the following 5 subscales are assessed by assigning number values to patients' responses, with 1 being most favourable and 4 being most unfavourable: Appearance, Symptoms, Consciousness, Satisfaction with Appearance and Satisfaction with Symptoms.
Measured: 2 months postoperatively
Individual Adverse Events to the RLN
An event wherein 50% reduction in EMG amplitude OR 10% latency is observed on CIONM.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized to have RLNs identified by lateral or medial approach. There are 3 relevant modalities of thyroidectomy within this study: total thyroidectomy, hemithyroidectomy and completion thyroidectomy. In total thyroidectomy, one side will receive the medial approach and one side with lateral approach, but the order and which lobe receives which will be randomized. For hemithyroidectomy and completion thyroidectomy, where one lobe is removed, randomization will dictate whether the lateral or medial approach to identifying the RLN will be used.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oleksandr Butskiy
- Sponsor type
- University, hospital or other
- Collaborators
- Inomed
- Responsible party
- Sponsor-investigator, Oleksandr Butskiy, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532889
- Sponsor's protocol ID
- H24-02160
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Continuous Nerve Monitoring to Compare Rates of Recurrent Laryngeal Nerve Injury Between Medial and Lateral Dissection Approaches to the Recurrent Laryngeal Nerve During a Thyroidectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07532889
- Acronym / sponsor ID
- H24-02160
- Conditions
- Thyroidectomy
- Keywords
- Thyroidectomy, Medial Approach to Thyroidectomy, Lateral Approach to Thyroidectomy, Continuous Nerve Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Oleksandr ButskiyUniversity, hospital or other
- Collaborators
- Inomed
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Apr 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.
The goal of this interventional study is to compare the effectiveness of two surgical approaches in identifying the recurrent laryngeal nerve (RLN) during thyroidectomy. The main questions it aims to answer are:
How does each approach affect the length of hospital stay? How does each approach affect the number of adverse events that occur during surgery? How does each approach affect vocal cord function after surgery?
Researchers will compare the new medial approach to the standard lateral approach to evaluate its effectiveness.
Participants scheduled to undergo thyroidectomy surgery will be randomly assigned to one of these approaches after informed consent is obtained. Data will be collected during and after the surgery by a research assistant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomized to have RLNs identified by lateral or medial approach. There are 3 relevant modalities of thyroidectomy within this study: total thyroidectomy, hemithyroidectomy and completion thyroidectomy. In total thyroidectomy, one side will receive the medial approach and one side with lateral approach, but the order and which lobe receives which will be randomized. For hemithyroidectomy and completion thyroidectomy, where one lobe is removed, randomization will dictate whether the lateral or medial approach to identifying the RLN will be used.
| Arm | Type | Receives |
|---|---|---|
| Medial Approach | Experimental | Procedure: Approach to RLN during ThyroidectomyFollowing the division of the isthmus, the edge on the resection side is grasped with Babcock forceps, placing it on lateral traction. The thyroid gland is then separated from the cricothyroid muscle and the trachea medially, leaving the berry's suspensory ligament adjacent to the first tracheal ring intact. The avascular space between the superior pole and the cricothyroid muscle is open. Finally, in the most critical step, the berry's ligament lateral to the first tracheal ring is placed on differential traction using two retractors - facilitating careful identification of the RLN as it courses under the superior edge of the berry's ligament - entering the larynx beneath the cricopharyngeus muscle. The RLN is identified at its most distal and consistent location as it enters the larynx. |
| Lateral Approach | Active comparator | Procedure: Approach to RLN during ThyroidectomyIn the lateral approach group, the superior thyroid pedicle is mobilized and ligated, followed by medial rotation of the thyroid gland with division of the middle thyroid vein. Then, the RLN is identified in between the tubercle of Zuckerkandl and the cricothyroid joint. Berry's suspensory ligament is then divided. The thyroid lobe will then be completely dissected from the trachea as the final step in lobectomy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing a total thyroidectomy or hemithyroidectomy under the care of the participating surgeons
Key exclusion criteria (8 listed)
- Age less than 19 years old
- Previous thyroid or parathyroid surgery, substernal goiter, preoperative vocal cord palsy (VCP)
- Evidence of lateral or central neck lymph node metastases
- Intentional iatrogenic transection of the RLN due to tumor invasion
- Failure to assess real-time RLN functioning due to equipment issues with the IONM setup
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 |
|---|---|---|
| Approach to RLN during ThyroidectomyMedial vs Lateral Approach to RLN during thyroidectomy | Procedure or surgery | Lateral Approach, Medial Approach |
Primary outcome
Intraoperative injury to the RLN
Time frame: Intraoperatively
1. LOS - as defined by a decline of amplitude to <100uV as measured by CIONM 2. Combined adverse events - an event wherein both 50% reduction in EMG amplitude and 10% latency are observed on CIONM
Temporary vocal cord palsy as defined endoscopically
Time frame: 2 weeks postoperatively
8 secondary outcomes
Hypoparathyroidism
Time frame: 6 months postoperatively
Postoperative hematoma requiring evacuation in the operating room
Time frame: Immediately following surgery
Postoperative hematoma not requiring evacuation in the operating room
Time frame: Immediately following surgery
Skin to skin operative time (minutes)
Time frame: Intraoperatively
Number of instances that the patient was randomized to a specific approach to identifying the RLN, but a different approach was taken by the surgeon
Time frame: Intraoperatively
Permanent vocal cord palsy as defined endoscopically
Time frame: 6 months postoperatively
Patient scar satisfaction score measured with Patient Scar Assessment Questionnaire (PSAQ)
Time frame: 2 months postoperatively
Individual Adverse Events to the RLN
Time frame: Intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Approach to RLN during Thyroidectomy in people with Thyroidectomy, run by Oleksandr Butskiy.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Intraoperative injury to the RLN (time frame: Intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.