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A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery

A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery - A Multicenter Prospective Trial to Evaluate the Efficacy of Minimally Invasive Hysterectomy Using an AI Program for Minimally Invasive Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060173
Enrollment
2600
Registered
2025-12-24
Start date
2025-12-26
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Patients undergoing total hysterectomy via minimally invasive surgery

Interventions

Use of an AI program for Minimally Invasive Hysterectomy

Sponsors

Department of Obstetrics and Gynecology, Showa Medical University / Gynecology, National Cancer Center Hospital East
Lead Sponsor
Jmees Co., Ltd.
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Adverse event rate for intraoperative or postoperative urinary tract (ureter or bladder) injury of Grade IIIa or higher

Secondary

MeasureTime frame
1. Adverse event rate of intraoperative and postoperative urinary tract injuries of Grade II or higher 2. Adverse event rate of intraoperative and postoperative urinary tract injuries of Grade I or higher 3. Surgeon stress level (Visual analogue scale using TLX score, etc.) 4. Contribution of the system to surgery (Visual analogue scale) 5. Contribution of the system to surgical education (Visual analogue scale)

Countries

Japan

Contacts

Public ContactMakoto Nakabayashi

Showa Medical University Department of Obstetrics and Gynecology

nakabayashi@med.showa-u.ac.jp03-3784-8551

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026