Evaluation of the Role of Intraoperative Neuromonitoring(IONM) in Patients Undergoing Parathyroid Surgery for Solitary Parathyroid Adenoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NON-IONM GROUP
Patients undergoing parathyroid surgery without intraoperative neuromonitoring.
IONM GROUP
Patients undergoing parathyroid surgery with intraoperative neuromonitoring.
干预措施: INTRAOPERATIVE NEUROMONITORING (Procedure)
结局指标
主要结局
Postoperative Vocal Cord Function, Reported as the Number and Percentage of Patients With Vocal Cord Dysfunction
时间窗: 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
次要结局
- Surgical Success According to the Miami Criterion, Reported as the Percentage of Patients Achieving a ≥50% Decrease in Intraoperative Parathyroid Hormone (IOPTH) Level(10th minute after parathyroidectomy)
- Operative Time, Reported in Minutes(During surgery)
- Incision Length, Reported in Millimeters(At the end of surgery)
研究者
Serkan Karaisli
ASSOCIATE PROFESSOR (MD) SERKAN KARAISLI
Izmir Katip Celebi University