Enhance Surgical Performance with Novel Kinematic Data Analytics in Robotic-Assisted Benign and Malignant (Endometrial) Hysterectomies

JRCT ID: jRCT1042210093

Registered date:30/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Benign and malignant uterine tumors (uterine cancer)
• Date of first enrollment: 13/02/2022
• Target sample size: 150
• Study type: Observational

Outcome(s)

Primary Outcome

Identify and describe objective performance indicators (OPIs) of the surgeon.

Typical OPIs are as follows
- Total distance traveled per arm, measured from the clevis position (kinematic efficiency)
- Total distance traveled per joint angle (radians), measured via roll, pitch, and yaw (wrist function)
- Distribution of velocity, acceleration, and jerk for each arm and joint angle
- Number of events and (Energy) time
- Smoothness
- Dexterity of both hands
- Instrument active and inactive time

Secondary Outcome

1.Examining the correlation between OPIs and clinical outcomes
- Examining the correlation between OPIs and clinical outcomes
- Correlation between OPIs and PROs

2.Evaluation of surgeon training by stratified analysis and matching analysis
- Comparison of OPIs and Clinical Outcomes between Expert and Novice Surgeon Groups
- Evaluation by group analysis in the benign and malignant groups

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

Patient who meet all of the following criteria will be eligible to participate in this study.
1.Patients aged 20 years or older
2.Patients who are indicated for hysterectomy for benign or malignant* tumors
*Malignant tumors are limited to uterine cancer.
3.Patients who have agreed to record surgical video, da Vinci system data, and Kinematic data using an Intuitive Data Recorder (IDR).
4.Patients who have provided written consent of their own free will to participate in this study after sufficient explanation and comprehension of the study.
5.Patients who can respond to the pre- and post-operative questionnaires as scheduled.

Exclude criteria

Patients who meet any one of the following criteria will not be allowed to participate in this study.
1.Patients with a history of severe glaucoma or cerebrovascular disease
2.Patients who have received robot-assisted hysterectomy for metastatic cancer.
3.Patients who have received robot-assisted hysterectomy for other major abdominal surgery
4.Patients with contraindications to surgical procedures or minimally invasive approaches
5.Patients with bleeding or coagulation disorders that may not be controlled during surgery.
6.Patients who are pregnant or suspected to be pregnant.
7.Patients who are unable to comply with the follow-up visit schedule.
8.Patients who are currently participating in other interventional studies.
9.Patients who are judged by the principal investigator or sub-investigator to be inappropriate as study subjects.

Related Information

• Primary Sponsor: Kondo Eiji
• Secondary Sponsor: Jarc Anthony,Intuitive Surgical , Inc.