Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Kern Medical Center
- Enrollment
- 50
- Primary Endpoint
- Vaginal cuff suturing time
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patient will not be told which surgical approaches were used during surgery
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Artisential laparoscopic instrument
Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Articulating laparoscopic instrument (Device)
Artisential laparoscopic instrument
Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Conventional laparoscopic instrument (Device)
Artisential laparoscopic instrument
Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Robotic surgical instrument (Device)
Conventional laparoscopic instrument
Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Articulating laparoscopic instrument (Device)
Conventional laparoscopic instrument
Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Conventional laparoscopic instrument (Device)
Conventional laparoscopic instrument
Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Robotic surgical instrument (Device)
Robotic instrument
Robotic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Articulating laparoscopic instrument (Device)
Robotic instrument
Robotic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Conventional laparoscopic instrument (Device)
Robotic instrument
Robotic instrument use for suturing during minimally invasive gynecologic surgery
Intervention: Robotic surgical instrument (Device)
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
- Surgical complications(Intraoperative)
- Knot tying times(Intraoperative)
- Knot location(Intraoperative)
- Needling times(Intraoperative)
Investigators
Yufan Chen
Chief, Division of Urogynecology, Department of Obstetrics and Gynecology
Kern Medical Center
