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Completed

NCT Number: NCT07836335

Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma

Aim: Intraoperative neuromonitoring (IONM) is frequently used in cases of primary hyperparathyroidism (pHPT); however, its role in cases of solitary parathyroid adenoma has not been clearly defined, and differing opinions exist on the matter. This study aimed to evaluate the impact of IONM on surgical outcomes in patients undergoing parathyroidectomy for solitary parathyroid adenoma.

Methods: Patients with localized solitary parathyroid adenoma were operated on by experienced endocrine surgeons at our clinic. Patients undergoing four-gland exploration or unilateral exploration, as well as those with a history of neck surgery and/or radiotherapy, were excluded from the study. Patient data were analyzed prospectively. Patients were divided into two groups: those who underwent IONM and those who did not. Demographic characteristics, preoperative and intraoperative data, and postoperative follow-up results were compared between the groups. The IONM procedure was performed in accordance with international IONM standards. Patients were randomized prior to surgery by a resident physician using a method where they drew a card from a bag.

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Key information

Conditions

Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid Adenoma Cranial Nerve Diseases Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Parathyroid Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Paralysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University Ataturk Training and Research Hospital

Izmir, İzmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being 18 years of age or older,
  • The adenoma being localized to the same location on both ultrasound and scintigraphy
  • No history of neck intervention for any reason,
  • No planned concurrent thyroid surgery or four-gland exploration,
  • Normal preoperative vocal cord assessment.

Exclusion criteria

  • Being under the age of 18,
  • Having undergone thyroid and parathyroid surgery,
  • Cases known to be familial preoperatively,
  • Cases scheduled for four-gland exploration,
  • Cases with a history of neck radiotherapy.

Treatment and study plan

INTRAOPERATIVE NEUROMONITORING

Procedure

INTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION.

Primary outcomes

  1. Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction

    Time frame: Postoperative Day 1 and 1 Week After Surgery

    Postoperative vocal cord function will be assessed by laryngoscopic examination and reported as the number and percentage of patients with normal or abnormal vocal cord function

Secondary outcomes

  1. Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level

    Time frame: 10th minute after parathyroidectomy

    Surgical success will be assessed according to the Miami criterion, defined as a ≥50% decrease in intraoperative parathyroid hormone (IOPTH) level from the highest pre-excision or baseline value to the 10-minute post-excision measurement. The outcome will be reported as the number and percentage of patients meeting the Miami criterion.

  2. Operative Time, Reported in Minutes

    Time frame: During surgery

    Operative time will be measured from the beginning of the surgical incision to completion of skin closure and will be reported in minutes.

  3. Incision Length, Reported in Millimeters

    Time frame: At the end of surgery

    The length of the surgical incision will be measured at the end of the surgical procedure and reported in millimeters.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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