臨床研究等提出・公開システム

Study on the Efficacy and Safety of Robotic Thyroid Surgery in Japan

Study of Robotic Thyroid Surgery in Japan

Fujiwara Kazunori

Tottori University Hospital

36-1, Nishicho, Yonago, Tottori

kfujiwa@tottori-u.ac.jp

Donishi Ryohei

Tottori University Hospital

36-1, Nishicho, Yonago, Tottori

+81-859-38-6627

ryohei-donishi@tottori-u.ac.jp

Recruiting

Mar. 03, 2025

Interventional

non-randomized controlled trial

open(masking not used)

historical control

single assignment

treatment purpose

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

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

Both

Thyroid nodule

Robotic surgical pricedure

Thyroid nodule

Robot

D016606

D065287

Postoperative recurrent laryngeal nerve palsy

# 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

+81-859-38-7021

Feb. 18, 2025

No

none