Clinical trial · Interventional
Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.
Phase III, Assessor Blinded, Randomised Controlled Trial of Use of Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery(ACTION)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Scientific objectives: Primary objective: • To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery Secondary objectives: * To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers * To assess voice parameters in patients with RLN palsy Methodology: All patients undergoing total thyroidectomy with or without central compartment neck dissection, for thyroid cancers, will be eligible for participation. After confirmation of eligibility and obtaining informed consent, all patients will undergo preoperative screening procedures. Fibreoptic laryngoscopy (FOL) examination will be done to document function of the vocal cords. Preoperative voiceevaluation, GRBAS voice scale assessment and Voice Related Quality of Life (VR-QOL) assessment will be performed for all patients. Patients will then be randomized in a 1:1 ratio to receive IONM or not during surgery. Patients will be stratified as per predefined stratification factors. After surgery, endpoint assessment of vocal cord mobility will be done with a FOL study, by an assessor blinded to the randomization arm. Voice evaluation, GRBAS scale assessment and VR QOL assessment will also be done. An event will be defined as any vocal fold paresis/palsy. Patients without the event will be followed up for 6 months while patients with the event will be followed up for 2 years to assess recovery of vocal cord function and changes in speech parameters. All patients with vocal cord paresis/palsy will be given speech and swallowing rehabilitation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Thyroid Gland | Malignant Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IONM tube | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IONM arm
- description
- Intra operative nerve monitoring (IONM) is a technique of monitoring the RLN during surgery, to help identification and safe guarding of the nerve during total thyroidectomy as well as central compartment clearance (CCC). This is a well established technique with many centers in the world routinely using monitoring during surgery.
- interventionNames
- Device: IONM tube
- type
- NO_INTERVENTION
- label
- Visual Identification arm
- description
- Patients randomized to this arm will undergo total thyroidectomy as per standard procedures with visual identification of the RLNs
Primary outcomes (1)
- measure
- Primary objective assessment (Temporary RLN palsy)- FOL evaluation
- timeFrame
- upto 21 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Total thyroidectomy with or without central compartment dissection * Redo total/completion thyroidectomy Exclusion Criteria: * Patients operated for benign diseases * Hemithyroidectomy * Pre operative cord fixity * High risk for intraoperative RLN sacrifice as determined by the treating surgeon * Redo patients undergoing unilateral procedures * Patients unwilling to participate in the trial
References
Publications (0)
Data not yet available