NIPH Clinical Trials Search

Study of Robotic Thyroid Surgery in Japan

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Thyroid nodule
Date of first enrollment	28/03/2025
Target sample size	46
Countries of recruitment
Study type	Interventional
Intervention(s)	Robotic surgical pricedure

Outcome(s)

Primary Outcome	Postoperative recurrent laryngeal nerve palsy
Secondary Outcome	# Surgical complications (postoperative hemorrhage, superior laryngeal nerve palsy, postoperative wound infection, unforeseen complications and their causes) # Chnages in the surgical procedure and the reasons # Intraoperative blood loss # Time from insertion of retractor for endoscopic surgery to closure of the wound # Length of hospital stay # Pain evaluation(NRS) # Adverse events

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 85age old
Gender	Both
Include criteria	Robot-assissted surgery group (1) Patients who are considered to require surgical treatment for thyroid tumors and meet any of the following conditions (1) Benign thyroid tumor (ii) Patients with preoperative staging of differentiated thyroid cancer limited to cT1-cT3, lymph node metastasis limited to cN1a, and M0 (no distant metastasis). (2) Patients who have given a full explanation of their participation in this study, and who have given written consent of their own free will based on full understanding. (3) Patients who are between 20 and 85 years of age at the time consent is obtained. Historical control group (1) Patients who have undergone endoscopic surgery for any of the following thyroid tumors between October 1, 2018 and December 31, 2024 (i) Benign thyroid tumor (ii) Patients with preoperative staging of differentiated thyroid cancer limited to cT1-cT3 and lymph node metastasis limited to cN1a and M0 (no distant metastasis). (2) Patients aged 20 to 85 years at the time of surgery
Exclude criteria	Robot-assissted surgery group 1) Patients with a history of neck or axillary surgery prior to thyroid surgery that would affect thyroid surgery 2) Patients with a history of radiation therapy to the neck 3) Patients with severe diabetes mellitus, preoperative administration of molecular targeted therapy, or other conditions that may delay postoperative wound healing 4) Patients who are deemed by the principal investigator or research physician to be inappropriate to participate in the study. Historical control group (1) Patients who have refused to opt out (2) Patients with a history of neck surgery before thyroid surgery that would affect thyroid surgery (3) Patients with a history of radiotherapy to the cervical region 4) Patients with severe diabetes mellitus, preoperative administration of molecular targeted therapy, or other conditions that may delay postoperative wound healing