Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of Artisential laparoscopic instruments in minimally invasive gynecologic surgery.

Detailed Description
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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.

Official Title
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Minimally Invasive Gynecologic Surgery Utilizing the Artisential Articulating Laparoscopic Instruments

Conditions
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Pelvic Organ Prolapse, Abnormal Uterine Bleeding, Mesh Augmentation, Laparoscopic Surgery, Robotic Surgical Suturing, Laparoscopic Hysterectomy, Minimally Invasive Surgery

Intervention / Treatment
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* Device: Articulating laparoscopic instrument
* Device: Conventional laparoscopic instrument
* Device: Robotic surgical instrument


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Those in the study scheduled for a laparoscopic hysterectomy will be randomly selected for the Artisential vs. Robotic vs. Laparoscopic vaginal cuff closure. Those in the study scheduled for sacrocolpopexy will have half the mesh sutured on by the primary surgical approach (robotic or laparoscopic) and the other half sutured on by the Artisential laparoscopic instrument
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artisential laparoscopic instrument<br>Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery | Device: Articulating laparoscopic instrument<br>* The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Artisential;Device: Conventional laparoscopic instrument<br>* Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Straight stick laparoscopy;Device: Robotic surgical instrument<br>* Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Da Vinci Robot;|
| Active Comparator: Conventional laparoscopic instrument<br>Conventional (straight stick) laparoscopic instrument use for suturing during minimally invasive gynecologic surgery | Device: Articulating laparoscopic instrument<br>* The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Artisential;Device: Conventional laparoscopic instrument<br>* Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Straight stick laparoscopy;Device: Robotic surgical instrument<br>* Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Da Vinci Robot;|
| Active Comparator: Robotic instrument<br>Robotic instrument use for suturing during minimally invasive gynecologic surgery | Device: Articulating laparoscopic instrument<br>* The Artisential articulating laparoscopic instrument will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Artisential;Device: Conventional laparoscopic instrument<br>* Conventional laparoscopic instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Straight stick laparoscopy;Device: Robotic surgical instrument<br>* Robotic surgical instruments will be evaluated for efficacy and safety in suturing during minimally invasive gynecologic surgery.<br>* Other names: Da Vinci Robot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh suturing time | Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times. | Intraoperative | 
| Vaginal cuff suturing time | Time to complete closure of the vaginal cuff | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needling times | Time to pass needle through tissue | Intraoperative | 
| Knot tying times | Time to tie a surgeon's knot, followed by 2 square knots | Intraoperative | 
| Knot location | Anterior vs. Posterior knot location | Intraoperative | 
| Surgical complications | List of any complications that occurred during the use of any of the 3 instrument types (Artisential, conventional laparoscopic, robotic) | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic surgery, Laparoscopic suturing, Laparoscopic instruments, Pelvic organ prolapse, Sacrocolpopexy, Minimally invasive surgery, Vaginal cuff closure