An interventional study of INTRAOPERATIVE NEUROMONITORING in Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid Adenoma, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Other
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.
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's enrollment of 100 is above the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
Patients undergoing parathyroid surgery with intraoperative neuromonitoring.
Procedure: INTRAOPERATIVE NEUROMONITORING
Patients undergoing parathyroid surgery without intraoperative neuromonitoring.
INTRAOPERATIVE NEUROMONITORING WAS USED DURING PARATHYROID SURGERY TO MONITOR RECURRENT LARYNGEAL NERVE FUNCTION.
Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
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
Time frame: Postoperative Day 1 and 1 Week After Surgery
Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level
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.
Time frame: 10th minute after parathyroidectomy
Operative Time, Reported in Minutes
Operative time will be measured from the beginning of the surgical incision to completion of skin closure and will be reported in minutes.
Time frame: During surgery
Incision Length, Reported in Millimeters
The length of the surgical incision will be measured at the end of the surgical procedure and reported in millimeters.
Time frame: At the end of surgery
Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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