CRANIO-CAUDAL AND LATERAL APPROACH FOR RECURRENT LARYNGEAL NERVE

NCT04379804 | Completed DMC

• 1 other identifier: CranioCaudal
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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).

Conditions

Recurrent Laryngeal Nerve Injuries

Keywords

cranio-caudal approach; lateral approach; intraoperative nerve monitoring

Outcome Measures

Primary Outcomes (1)

• Recurrent laryngeal nerve injury

  Gross anatomical injury or functional injury demonstrated by nerve monitoring

  6 months postoperatively

Secondary Outcomes (3)

• Serum levels of calcium

  First day postoperatively

• Serum levels of parathormone

  First day postoperatively

• Recovery of EMG changes

  20 minutes after initial EMG changes

Study Arms (2)

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.

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Following the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle.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

Procedure: Cranio-caudal approach

Interventions

Lateral approach PROCEDURE

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).

Lateral approach

Cranio-caudal approach PROCEDURE

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

Cranio-caudal approach

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Multinoduler Goitre
• Thyroid papillary cancer
• Solitary thyroid nodule

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

Study Sites (1)

Istanbul University

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Yalin İscan

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Specialist

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: May 8, 2020
• Study Start: June 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: March 1, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)