Recurrent Laryngeal Nerve InjuriesNCT04379804
CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE
A study testing Lateral approach and Cranio-caudal approach in people with Recurrent Laryngeal Nerve Injuries, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The recurrent laryngeal nerve (RLN) dissection should be performed cranio-caudally in TOETVA approach.The aim of this study was to compare the cranio-caudal and lateral approach for RLN dissection in regard with the rates of LOS during conventional thyroidectomy using continuous intraoperative nerve monitoring (CIONM). Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Laryngeal Nerve Injuries
- What is being tested?
- Lateral approach and Cranio-caudal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Mar 2020
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Multinoduler Goitre
- Thyroid papillary cancer
- Solitary thyroid nodule
Who cannot join
- previous thyroid or parathyroid surgery,
- substernal goiter,
- preoperative VCP,
- evidence of lateral lymph node metastasis,
- intentional transection of the RLN due to tumor invasion,
- failure to assess RLN functioning due to equipment issues with the IONM setup,
- presurgical dissection amplitude of <500µV,
- patient's refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF THE INCIDENCE OF RECURRENT LARYNGEAL INJURY FOLLOWING THE DISSECTİON OF THE NERVE BY CRANIO-CAUDAL AND LATERAL APPROACH BY USING INTROPERATIVE NERVE MONITORING
The recurrent laryngeal nerve (RLN) dissection should be performed cranio-caudally in TOETVA approach.The aim of this study was to compare the cranio-caudal and lateral approach for RLN dissection in regard with the rates of LOS during conventional thyroidectomy using continuous intraoperative nerve monitoring (CIONM).
Read the detailed description
During the thyroid surgery, the identification of the recurrent laryngeal nerve (RLN) and the dissection through its entry point is still the gold standard in prevention of the nerve injury and to decrease the RLN palsy rate. Intraoperative nerve monitoring (IONM) has also so many benefits to search, identify and dissect the nerve through its course during thyroid surgery and especially the most important benefit of the IONM is to have real time information about the function of the RLN. Most of the endocrine surgeons use the inferolateral approach for RLN identification under the guidance of the IONM in the recent years. However after the definition of the transoral endoscopic thyroidectomy vestibular approach (TOETVA) technique, the approach to the RLN have to be changed to craniocaudal approach in which a way that most of the surgeons are not familiar with. The different approaches of the recurrent laryngeal nerve depend on the indications and on the surgeon's habit. Several approaches exist such as the superior approach ,the lateral approach, and the inferior approach.
- Conditions
- Recurrent Laryngeal Nerve Injuries
- Being tested
- Lateral approach, Cranio-caudal approach
- Keywords
- cranio-caudal approach, lateral approach, intraoperative nerve monitoring
- Medical subject headings
- Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral approachProcedure or surgery
Following the ligation of upper pole vessels, the thyroid lobe was pulled anteromedially and the RLN was dissected within the carotid triangle at the level of inferior thyroid artery (ITA).
Cranio-caudal approachProcedure or surgery
Following the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle. The RLN was identified at the point of entry both visually and with hand held stimulation probe
| Study group | Role | What they receive |
|---|---|---|
| Lateral approach | Active comparator | Following the ligation of upper pole vessels, the thyroid lobe lobe was pulled anteromedially and the RLN was dissected within the carotid triangle at the level of inferior thyroid artery. The tissue between the carotid artery and the trachea was dissected gently parallel to the direction of the nerve until the nerve is identified visually and,or by hand held stimulation probe. After the identification of RLN, the vessels of inferior thyroid lobe was ligated. The nerve was dissected along its course to the entry point, and then the thyroid lobe was totally dissected from the trachea and the lobectomy was completed. If adverse EMG changes were encountered during lateral approach, traction was released immediately and waited for recovery. Receives: Procedure: Lateral approach |
| Cranio-caudal approach | Active comparator | Following the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle. The RLN nerve was identified at the point of entry both visually and with hand held stimulation probe. The RLN dissection was proceeded craniocaudally by the division of the suspensory ligaments of the berry through the level of inferior thyroid artery. After the identification and visualitzation of the RLN through its whole course, the medial and inferior vessels of the thyroid gland were dissected and ligated. Then, the lobe was dissected from the trachea and lobectomy was completed. Receives: Procedure: Cranio-caudal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent laryngeal nerve injury
Gross anatomical injury or functional injury demonstrated by nerve monitoring
Measured: 6 months postoperatively
Secondary outcomes (3)
Serum levels of calcium
On the first postoperative day to identify hypocalcemia
Measured: First day postoperatively
Serum levels of parathormone
On the first postoperative day to identify hypoparathyroidism
Measured: First day postoperatively
Recovery of EMG changes
adverse EMG parameters were defined as amplitude decrease of 50% or more of baseline value and,or latency increase of 10% or more
Measured: 20 minutes after initial EMG changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Jun 2018
- Primary completion30 Nov 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Laryngeal Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Responsible party
- Principal investigator, Yalin Iscan, MD, Istanbul University
- Investigators
- Yalin İscan, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379804
- Sponsor's protocol ID
- CranioCaudal
- Status last verified
- May 2020
- First submitted
- 18 Apr 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE INCIDENCE OF RECURRENT LARYNGEAL INJURY FOLLOWING THE DISSECTİON OF THE NERVE BY CRANIO-CAUDAL AND LATERAL APPROACH BY USING INTROPERATIVE NERVE MONITORING
- ClinicalTrials.gov ID
- NCT04379804
- Acronym / sponsor ID
- CranioCaudal
- Conditions
- Recurrent Laryngeal Nerve Injuries
- Keywords
- cranio-caudal approach, lateral approach, intraoperative nerve monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 8 May 2020 (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 recurrent laryngeal nerve (RLN) dissection should be performed cranio-caudally in TOETVA approach.The aim of this study was to compare the cranio-caudal and lateral approach for RLN dissection in regard with the rates of LOS during conventional thyroidectomy using continuous intraoperative nerve monitoring (CIONM).
Detailed description
During the thyroid surgery, the identification of the recurrent laryngeal nerve (RLN) and the dissection through its entry point is still the gold standard in prevention of the nerve injury and to decrease the RLN palsy rate. Intraoperative nerve monitoring (IONM) has also so many benefits to search, identify and dissect the nerve through its course during thyroid surgery and especially the most important benefit of the IONM is to have real time information about the function of the RLN. Most of the endocrine surgeons use the inferolateral approach for RLN identification under the guidance of the IONM in the recent years. However after the definition of the transoral endoscopic thyroidectomy vestibular approach (TOETVA) technique, the approach to the RLN have to be changed to craniocaudal approach in which a way that most of the surgeons are not familiar with. The different approaches of the recurrent laryngeal nerve depend on the indications and on the surgeon's habit. Several approaches exist such as the superior approach ,the lateral approach, and the inferior approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral approach | Active comparator | Procedure: Lateral approachFollowing the ligation of upper pole vessels, the thyroid lobe lobe was pulled anteromedially and the RLN was dissected within the carotid triangle at the level of inferior thyroid artery. The tissue between the carotid artery and the trachea was dissected gently parallel to the direction of the nerve until the nerve is identified visually and,or by hand held stimulation probe. After the identification of RLN, the vessels of inferior thyroid lobe was ligated. The nerve was dissected along its course to the entry point, and then the thyroid lobe was totally dissected from the trachea and the lobectomy was completed. If adverse EMG changes were encountered during lateral approach, traction was released immediately and waited for recovery. |
| Cranio-caudal approach | Active comparator | Procedure: Cranio-caudal approachFollowing the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle. The RLN nerve was identified at the point of entry both visually and with hand held stimulation probe. The RLN dissection was proceeded craniocaudally by the division of the suspensory ligaments of the berry through the level of inferior thyroid artery. After the identification and visualitzation of the RLN through its whole course, the medial and inferior vessels of the thyroid gland were dissected and ligated. Then, the lobe was dissected from the trachea and lobectomy was completed. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Multinoduler Goitre
- Thyroid papillary cancer
- Solitary thyroid nodule
Key exclusion criteria (8 listed)
- previous thyroid or parathyroid surgery,
- substernal goiter,
- preoperative VCP,
- evidence of lateral lymph node metastasis,
- intentional transection of the RLN due to tumor invasion,
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 |
|---|---|---|
| Lateral approachFollowing the ligation of upper pole vessels, the thyroid lobe was pulled anteromedially and the RLN was dissected within the carotid triangle at the level of inferior thyroid artery (ITA). | Procedure or surgery | Lateral approach |
| Cranio-caudal approachFollowing the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle. The RLN was identified at the point of entry both visually and with hand held stimulation probe | Procedure or surgery | Cranio-caudal approach |
Primary outcome
Recurrent laryngeal nerve injury
Time frame: 6 months postoperatively
Gross anatomical injury or functional injury demonstrated by nerve monitoring
3 secondary outcomes
Serum levels of calcium
Time frame: First day postoperatively
Serum levels of parathormone
Time frame: First day postoperatively
Recovery of EMG changes
Time frame: 20 minutes after initial EMG changes
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 11 May 2020.
- Individual participant dataSharing planned: No
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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.
Yalin İscan principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral approach and Cranio-caudal approach in people with Recurrent Laryngeal Nerve Injuries, run by Istanbul 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 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: finished, as of the sponsor's last update on 11 May 2020. 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?
Recurrent laryngeal nerve injury (time frame: 6 months postoperatively). 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 11 May 2020.