Patients undergoing total hysterectomy via minimally invasive surgery
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Adverse event rate for intraoperative or postoperative urinary tract (ureter or bladder) injury of Grade IIIa or higher | — |
Secondary
| Measure | Time 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
Showa Medical University Department of Obstetrics and Gynecology