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A Study Comparing Thyroid Surgery With Nerve Monitoring Versus Conventional Surgery for Prevention of Voice Nerve Injury

Intraoperative Nerve Monitoring (IONM) with Visual Identification versus Visual Identification Alone in Thyroid Surgery A Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099464
Enrollment
60
Registered
2025-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E079- Disorder of thyroid, unspecified

Interventions

Intervention1: Intraoperative Nerve Monitoring (IONM) with Visual Identification in thyroid surgery: Intraoperative Nerve Monitoring (IONM) with Visual Identification in thyroid surgery to look for ra

Sponsors

Dr Tridib Kumar Amat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged more than 18 years undergoing thyroid surgery. Patients with benign or malignant thyroid disease. Patients who provide written informed consent. Preoperative normal vocal cord function as assessed by indirect laryngoscopy

Exclusion criteria

Exclusion criteria: Previous thyroid or neck surgery (revision thyroidectomy). Preoperative vocal cord palsy. History of neck radiation. Known allergy to anaesthetic agents used during nerve monitoring. Severe comorbidities making general anaesthesia unsafe. Pregnancy.

Design outcomes

Primary

MeasureTime frame
To determine and compare the incidence of recurrent laryngeal nerve (RLN) injury in thyroid surgery using intraoperative nerve monitoring (IONM) with visual identification versus visual identification alone.Timepoint: It will be acessed immediate postoperatively ,then at 1 and 3 rd month by doing indirect layngoscope .

Secondary

MeasureTime frame
To compare the time taken to identify the RLN in both groups. To assess postoperative vocal cord function. To estimate overall operative time & postoperative complication rates. To evaluate the cost-effectiveness of intraoperative nerve monitoring (IONM) compared to visual identification in terms of surgical outcomes, complication rates, & healthcare resource utilization Timepoint: Length of hospital stay Post operative complication will be checked during hospital stay.

Countries

India

Contacts

Public ContactDr Yashwant Lamture

All India Institute of Medical Sciences ,Nagpur

yash18671@gmail.com9960371205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026