Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Kern Medical Center
- Enrollment
- 50
- Primary Endpoint
- Vaginal cuff suturing time
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.
Detailed Description
The Artisential laparoscopic instrument is a novel device that allows multi-directional articulation during laparoscopic surgery. There are currently no studies evaluating the efficacy or safety of this device in minimally invasive gynecologic surgery. The investigators aim to compare the efficacy and safety of the Artisential instrument with conventional laparoscopic or robotic instruments. Patients who are scheduled for a laparoscopic or robotic hysterectomy and/or laparoscopic or robotic sacrocolpopexy will be invited to participate in this study. During the suturing portion of the surgery (either vaginal cuff closure during a hysterectomy, or mesh attachment during a sacrocolpopexy), operating times and safety outcomes will be measured. The approach for vaginal cuff closure will be randomly selected. The approach for mesh attachment suturing will be based on the primary surgical approach (conventional laparoscopy or robotic) and compared to suturing with the Artisential and an internally controlled environment. Therefore, half of the knots placed during a case will be with the Artisential laparoscopic device, and the other half will be placed either with robotic instruments or conventional laparoscopic instruments.
Investigators
Yufan Chen
Chief, Division of Urogynecology, Department of Obstetrics and Gynecology
Kern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patient scheduled for robotic or laparoscopic total hysterectomy
- •Patient scheduled for robotic or laparoscopic sacrocolpopexy
Exclusion Criteria
- •Not a candidate for the above surgical procedures
Outcomes
Primary Outcomes
Vaginal cuff suturing time
Time Frame: Intraoperative
Time to complete closure of the vaginal cuff
Mesh suturing time
Time Frame: Intraoperative
Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.
Secondary Outcomes
- Knot tying times(Intraoperative)
- Knot location(Intraoperative)
- Needling times(Intraoperative)
- Surgical complications(Intraoperative)