Tokyo, Dec. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060173) titled 'A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery' on Dec. 24.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Department of Obstetrics and Gynecology, Showa Medical University / Gynecology, National Cancer Center Hospital East
Condition:
Condition - Patients undergoing total hysterectomy via minimally invasive surgery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Verification of the Usefulness of an AI Program for Minimally Invasive Surgery
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Use of an AI program for Minimally Invasive Hysterectomy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - Patients undergoing total hysterectomy via minimally invasive surgery
Must meet all of the following eligibility criteria:
1.Adult patients scheduled for laparoscopic or robot-assisted total hysterectomy
2.Patients who have provided written informed consent to participate in this study of their own free will
Physicians using this system
Surgeons and assistants who use this system for laparoscopic or robot-assisted total hysterectomy. However, participation is limited to surgeons and assistants who have never used SurVisHys, or who have used it in 10 or fewer cases and have not used it for at least 3 months at the time of participation.
Key exclusion criteria - Patients undergoing total hysterectomy via minimally invasive surgery
Must not meet any of the following exclusion criteria:
1.Minors
2.Patients deemed unsuitable for participation in this study by their attending physician
3.Patients judged to have a high risk of urinary tract injury preoperatively and scheduled to receive ureteral stent placement
Physicians using this system
Physicians deemed unsuitable for participation in this study by the principal investigator at each facility. However, in principle, we plan to collect questionnaire responses from all physicians capable of responding.
Target Size - 2200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 01 Day
Date of IRB - 2025 Year 12 Month 05 Day
Anticipated trial start date - 2025 Year 12 Month 26 Day
Last follow-up date - 2027 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068776
Disclaimer: Curated by HT Syndication.
