Recurrent Laryngeal Nerve InjuriesNCT03907761
Hydrodissection of Recurrent Laryngeal Nerve: Case Series
An observational study of Recurrent Laryngeal Nerve Injuries, run by Ankara University.
Trial summary
This study evaluates the hydrodissection technique in recurrent laryngeal nerve (RLN) dissection in thyroid surgeries. In this study hydrodissection of RLN was performed routinely in thyroid surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Laryngeal Nerve Injuries
- What is being tested?
- Hydrodissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 31 Dec 2018
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all the patients undergoing to thyroidectomy for thyroid nodules
Who may be able to join
- patients undergoing thyroidectomy for various thyroid diseases
Who cannot join
- patients in whom RLN palsy detected by indirect laryngoscopy before surgery
About this study
This study evaluates the hydrodissection technique in recurrent laryngeal nerve (RLN) dissection in thyroid surgeries. In this study hydrodissection of RLN was performed routinely in thyroid surgeries.
Read the detailed description
Thyroid surgery is one of the most frequently performed surgical procedures. Recurrent laryngeal nerve (RLN) injury is the most annoying complication of thyroid surgery. According to literature 0.5-5% and 1-30% of patients is reported to have permanent or temporary RLN injury after the surgery, respectively.
RLN innervates all intrinsic muscles of larynx with the exception of cricothyroid muscle. Injury of RLN causes vocal cord paralysis. Unilateral RLN injury causes hoarseness, but when RLNs are bilaterally damaged aspiration during swallowing or life threatening dyspnea can occur according to severity of glottal narrowing.
Hydrodissection is described in laparoscopic cholecystectomy, cataract surgery, carpal tunnel syndrome treatment where meticulous dissection must be carried out as mentioned above. This technique helps exploring anatomical landmarks by gentle dissection without giving harm to tissues. In thyroid surgery hydrodissection is performed to dissect foamy planes and increase visualization of RLN by high velocity stream of warm saline. Despite being used extensively in routine clinical practice to our best knowledge no report evaluating hydrodissection in thyroid surgery exists in the literature up to date.
In this study, investigators aimed to assess the incidence of RLN damage observed in our series by hydrodissection of RLN during thyroid surgery.
To prevent RLN damage, a good knowledge of anatomy and surgeon's experience are crucial. Routine visualization of RLN along tracheoesophageal sulcus, following the course of RLN near suspensory ligament of berry ligament until entering the larynx is recommended to avoid RLN injury. But still some surgeons declare that visualization of RLN is not possible in all operations. Therefore staying close to thyroid capsule during thyroidectomy is considered to be a good surgical practice to preserve the nerve.
Accurate knowledge of RLN anatomical variations, RLN landmarks such as relation of the nerve with inferior thyroid artery branches, berry ligament, inferior horn of thyroid cartilage during thyroidectomy, is essential as mentioned in the literature. Also inflammatory processes of thyroid (thyroiditis), large nodules, previous operations can change the course of nerve. Hence meticulous dissection of RLN should be performed. In simple thyroidectomies lateral or inferior dissection of RLN is the most common approach but in challenging cases such as large nodules, plunging thyroid gland, neck extension limitations, superior approach, craniocaudal dissection of RLN is accepted to be more appropriate . In our study, both lateral and superior approach were used, hydrodissection of foamy tissue and visualization of the nerve by removing blood and debris via high velocity stream of saline was the main point.
Today, various methods of nerve monitoring and stimulation techniques are in use. Intraoperative nerve monitoring (IONM) significantly reduces iatrogenic RLN injury, helps identification of nerve especially in cases with anatomical variations and points early warning of nerve injury. But disadvantages of IONM like improper electrode position leading to nerve damage must be kept in mind. In the study investigators used IONM in only one case which had a story of RLN injury at the previously operated site. Hydrodissection of RLN is also helpful in use of IONM by allowing dissection of the planes gently just like the gas does in laparoscopy. In our country, since government does not pay for it, investigators cannot use IONM routinely. However hydrodissection is an easily applicable, non time-consuming and cheap technique.
In this study consecutive patients underwent thyroidectomy for various thyroid diseases by one surgeon were included in the study. All the patients' demographic variables (age, sex), operation type (bilateral total thyroidectomy, hemithyroidectomy (total lobectomy and isthmectomy), completion total thyroidectomy, whether central neck compartment dissection was performed), pathology reports, nerves at risk were noted retrospectively. RLN exploration was routinely done to avoid nerve damage on the resected lobe side. Hydrodissection technique was performed while exploring RLNs differently from routine thyroidectomies. For hydrodissection a 10 ml syringe was used with a needle of 1 cm length. After ligation of middle thyroid vein and superior thyroid vessels, the thyroid lobe gently retracted medially and carotid arter laterally by retractors, hydrodissection was performed by high velocity stream of warm-normal saline to the foamy dissection area of RLN and berry ligament (Ethical approval was obtained).RLN detection and dissections were performed with hydrodissection. High velocity stream of normal saline is given to the dissection area by an 10 ml syringe. This dissected all the planes in the field like gas insufflation does in laparoscopic surgery . This technique helped RLN dissection without giving harm to any tissue and nerve itself. RLN integrity was checked by mobility of vocal cords 3 days prior to surgery, postoperative 3. day of surgery and if any movement change deteceted at postoperative 3. day, also reevaluation was made 1 month after the surgery. Also during extubation after operation completed, vocal cord movements are checked by direct visualization.
- Conditions
- Recurrent Laryngeal Nerve Injuries
- Being tested
- Hydrodissection
- Keywords
- thyroidectomy, recurrent laryngeal nerve, hydrodissection
- 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.
HydrodissectionProcedure or surgery
high velocity stream of normal saline is given to the dissection area by help of 10 ml syringe
What is being measured
The primary outcome is the main question the study is designed to answer.
mobility of vocal cords preoperative to thyroid surgery
to assess if there is RLN palsy prior thyroidectomy operation preoperative evaluation of vocal cords by indirect laryngoscopy were performed 3 days prior to surgery routinely.
Measured: 3 days before surgery
Secondary outcomes (2)
mobility of vocal cords at the postoperative 3. day
to evaluate the RLN injury after thyroidectomy with hydrodissection operation, at the postoperative 3. day, vocal cord damage was evaluated with indirect laryngoscopy
Measured: 3 days after thyroidectomy
mobility of vocal cord at the injured side
if there was a RLN damage after the operation detected by indirect laryngoscopy at postoperative 3. day, vocal cord movement at the injured side will be reevaluated by indirect laryngoscopy
Measured: 1 month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Feb 2016
- Primary completion31 Aug 2017
- Study completion31 Dec 2018
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Akbulut, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907761
- Sponsor's protocol ID
- 06-480-19
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- 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 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrodissection of Recurrent Laryngeal Nerve: Case Series
- ClinicalTrials.gov ID
- NCT03907761
- Acronym / sponsor ID
- 06-480-19
- Conditions
- Recurrent Laryngeal Nerve Injuries
- Keywords
- thyroidectomy, recurrent laryngeal nerve, hydrodissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Apr 2019 (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 study evaluates the hydrodissection technique in recurrent laryngeal nerve (RLN) dissection in thyroid surgeries. In this study hydrodissection of RLN was performed routinely in thyroid surgeries.
Detailed description
Thyroid surgery is one of the most frequently performed surgical procedures. Recurrent laryngeal nerve (RLN) injury is the most annoying complication of thyroid surgery. According to literature 0.5-5% and 1-30% of patients is reported to have permanent or temporary RLN injury after the surgery, respectively.
RLN innervates all intrinsic muscles of larynx with the exception of cricothyroid muscle. Injury of RLN causes vocal cord paralysis. Unilateral RLN injury causes hoarseness, but when RLNs are bilaterally damaged aspiration during swallowing or life threatening dyspnea can occur according to severity of glottal narrowing.
Hydrodissection is described in laparoscopic cholecystectomy, cataract surgery, carpal tunnel syndrome treatment where meticulous dissection must be carried out as mentioned above. This technique helps exploring anatomical landmarks by gentle dissection without giving harm to tissues. In thyroid surgery hydrodissection is performed to dissect foamy planes and increase visualization of RLN by high velocity stream of warm saline. Despite being used extensively in routine clinical practice to our best knowledge no report evaluating hydrodissection in thyroid surgery exists in the literature up to date.
In this study, investigators aimed to assess the incidence of RLN damage observed in our series by hydrodissection of RLN during thyroid surgery.
To prevent RLN damage, a good knowledge of anatomy and surgeon's experience are crucial. Routine visualization of RLN along tracheoesophageal sulcus, following the course of RLN near suspensory ligament of berry ligament until entering the larynx is recommended to avoid RLN injury. But still some surgeons declare that visualization of RLN is not possible in all operations. Therefore staying close to thyroid capsule during thyroidectomy is considered to be a good surgical practice to preserve the nerve.
Accurate knowledge of RLN anatomical variations, RLN landmarks such as relation of the nerve with inferior thyroid artery branches, berry ligament, inferior horn of thyroid cartilage during thyroidectomy, is essential as mentioned in the literature. Also inflammatory processes of thyroid (thyroiditis), large nodules, previous operations can change the course of nerve. Hence meticulous dissection of RLN should be performed. In simple thyroidectomies lateral or inferior dissection of RLN is the most common approach but in challenging cases such as large nodules, plunging thyroid gland, neck extension limitations, superior approach, craniocaudal dissection of RLN is accepted to be more appropriate . In our study, both lateral and superior approach were used, hydrodissection of foamy tissue and visualization of the nerve by removing blood and debris via high velocity stream of saline was the main point.
Today, various methods of nerve monitoring and stimulation techniques are in use. Intraoperative nerve monitoring (IONM) significantly reduces iatrogenic RLN injury, helps identification of nerve especially in cases with anatomical variations and points early warning of nerve injury. But disadvantages of IONM like improper electrode position leading to nerve damage must be kept in mind. In the study investigators used IONM in only one case which had a story of RLN injury at the previously operated site. Hydrodissection of RLN is also helpful in use of IONM by allowing dissection of the planes gently just like the gas does in laparoscopy. In our country, since government does not pay for it, investigators cannot use IONM routinely. However hydrodissection is an easily applicable, non time-consuming and cheap technique.
In this study consecutive patients underwent thyroidectomy for various thyroid diseases by one surgeon were included in the study. All the patients' demographic variables (age, sex), operation type (bilateral total thyroidectomy, hemithyroidectomy (total lobectomy and isthmectomy), completion total thyroidectomy, whether central neck compartment dissection was performed), pathology reports, nerves at risk were noted retrospectively. RLN exploration was routinely done to avoid nerve damage on the resected lobe side. Hydrodissection technique was performed while exploring RLNs differently from routine thyroidectomies. For hydrodissection a 10 ml syringe was used with a needle of 1 cm length. After ligation of middle thyroid vein and superior thyroid vessels, the thyroid lobe gently retracted medially and carotid arter laterally by retractors, hydrodissection was performed by high velocity stream of warm-normal saline to the foamy dissection area of RLN and berry ligament (Ethical approval was obtained).RLN detection and dissections were performed with hydrodissection. High velocity stream of normal saline is given to the dissection area by an 10 ml syringe. This dissected all the planes in the field like gas insufflation does in laparoscopic surgery . This technique helped RLN dissection without giving harm to any tissue and nerve itself. RLN integrity was checked by mobility of vocal cords 3 days prior to surgery, postoperative 3. day of surgery and if any movement change deteceted at postoperative 3. day, also reevaluation was made 1 month after the surgery. Also during extubation after operation completed, vocal cord movements are checked by direct visualization.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all the patients undergoing to thyroidectomy for thyroid nodules
Key inclusion criteria (1 listed)
- patients undergoing thyroidectomy for various thyroid diseases
Key exclusion criteria (1 listed)
- patients in whom RLN palsy detected by indirect laryngoscopy before surgery
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 |
|---|---|---|
| Hydrodissectionhigh velocity stream of normal saline is given to the dissection area by help of 10 ml syringe | Procedure or surgery | – |
Primary outcome
mobility of vocal cords preoperative to thyroid surgery
Time frame: 3 days before surgery
to assess if there is RLN palsy prior thyroidectomy operation preoperative evaluation of vocal cords by indirect laryngoscopy were performed 3 days prior to surgery routinely.
2 secondary outcomes
mobility of vocal cords at the postoperative 3. day
Time frame: 3 days after thyroidectomy
mobility of vocal cord at the injured side
Time frame: 1 month after the operation
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 9 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Laryngeal Nerve Injuries, run by Ankara University.
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 1 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 9 Apr 2019. 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?
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?
mobility of vocal cords preoperative to thyroid surgery (time frame: 3 days before surgery). 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 9 Apr 2019.