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CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

Primary Purpose

Recurrent Laryngeal Nerve Injuries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lateral approach
Cranio-caudal approach
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Laryngeal Nerve Injuries focused on measuring cranio-caudal approach, lateral approach, intraoperative nerve monitoring

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Multinoduler Goitre
  • Thyroid papillary cancer
  • Solitary thyroid nodule

Exclusion criteria:

  • 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

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lateral approach

Cranio-caudal approach

Arm Description

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.

Following the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle.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.

Outcomes

Primary Outcome Measures

Recurrent laryngeal nerve injury
Gross anatomical injury or functional injury demonstrated by nerve monitoring

Secondary Outcome Measures

Serum levels of calcium
On the first postoperative day to identify hypocalcemia
Serum levels of parathormone
On the first postoperative day to identify hypoparathyroidism
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

Full Information

First Posted
April 18, 2020
Last Updated
May 7, 2020
Sponsor
Istanbul University
Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04379804
Brief Title
CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Laryngeal Nerve Injuries
Keywords
cranio-caudal approach, lateral approach, intraoperative nerve monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Computer generated random numbers were generated and printed on cards. These cards were placed in sealed, opaque envelopes. On the morning of operation, one envelope was opened before the operation and, depending of the parity of the number, RLN's of the patient were dissected either by cranio-caudal or lateral dissection during the operation.
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lateral approach
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cranio-caudal approach
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lateral approach
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Cranio-caudal approach
Intervention Description
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
Primary Outcome Measure Information:
Title
Recurrent laryngeal nerve injury
Description
Gross anatomical injury or functional injury demonstrated by nerve monitoring
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
Serum levels of calcium
Description
On the first postoperative day to identify hypocalcemia
Time Frame
First day postoperatively
Title
Serum levels of parathormone
Description
On the first postoperative day to identify hypoparathyroidism
Time Frame
First day postoperatively
Title
Recovery of EMG changes
Description
adverse EMG parameters were defined as amplitude decrease of 50% or more of baseline value and,or latency increase of 10% or more
Time Frame
20 minutes after initial EMG changes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Multinoduler Goitre Thyroid papillary cancer Solitary thyroid nodule Exclusion criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yalin İscan
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34752
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

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