Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery

Not Applicable

Not yet recruiting

• Conditions: Mesh Augmentation; Robotic Surgical Suturing; Laparoscopic Surgery; Minimally Invasive Surgery; Pelvic Organ Prolapse; Laparoscopic Hysterectomy; Abnormal Uterine Bleeding
• Interventions: Device: Articulating laparoscopic instrument; Device: Conventional laparoscopic instrument; Device: Robotic surgical instrument

• Registration Number: NCT06050161
• Lead Sponsor: Kern Medical Center

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 Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2023-09-17
• Last Update Submitted: 2023-09-17
• Study Start: 2023-09-20
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2027-09-20
• Study Completion: 2027-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Artisential laparoscopic instrument	Conventional laparoscopic instrument	Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Conventional laparoscopic instrument	Articulating laparoscopic instrument	Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Robotic instrument	Articulating laparoscopic instrument	Robotic instrument use for suturing during minimally invasive gynecologic surgery
Artisential laparoscopic instrument	Articulating laparoscopic instrument	Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Robotic instrument	Robotic surgical instrument	Robotic instrument use for suturing during minimally invasive gynecologic surgery
Artisential laparoscopic instrument	Robotic surgical instrument	Artisential laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Conventional laparoscopic instrument	Conventional laparoscopic instrument	Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Conventional laparoscopic instrument	Robotic surgical instrument	Conventional ("straight stick") laparoscopic instrument use for suturing during minimally invasive gynecologic surgery
Robotic instrument	Conventional laparoscopic instrument	Robotic instrument use for suturing during minimally invasive gynecologic surgery

Primary Outcome Measures

Name	Time	Method
Vaginal cuff suturing time	Intraoperative	Time to complete closure of the vaginal cuff
Mesh suturing time	Intraoperative	Time to complete 2 full knots. This includes needling times, knot tying times, and suture cutting times.

Secondary Outcome Measures

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