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

Izmir Katip Celebi University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Evaluation of the Role of IONM in Minimally Invasive Parathyroidectomy Performed for Solitary Parathyroid Adenoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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