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Study of Robotic Thyroid Surgery in Japan

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062240130
Enrollment
46
Registered
2025-03-03
Start date
2025-03-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid nodule Thyroid nodule

Interventions

Robotic surgical pricedure

Sponsors

Fujiwara Kazunori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Postoperative recurrent laryngeal nerve palsy

Secondary

MeasureTime frame
# 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

Contacts

Public ContactRyohei Donishi

Tottori University Hospital

ryohei-donishi@tottori-u.ac.jp+81-859-38-6627

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026