Comparison of Three Robotic Platforms for Hysterectomy

Study Overview
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Brief Summary
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Hysterectomy is the most common procedure in gynaecology after a cesarean section. In recent years, the laparoscopic approach has become preferred given the different advantages over the traditional laparotomic approach, and both conventional laparoscopy and robotic-assisted laparoscopy have become the standard approach for hysterectomy. To date, robotic-assisted laparoscopic hysterectomy has been performed using one robotic platform and only recently, two new robotic platforms have been introduced in clinical practice. Although all three are registered for human use and available for clinical practice, there are currently not enough clinical experiences and data in the literature to evaluate the efficacy, safety and relationship between cost and efficacy of the new platforms available for the robotic-assisted laparoscopic hysterectomy. For this reason, the investigators will conduct an exploratory clinical study on a Post Market Clinical Follow up (PMCF) medical device aimed at performing a preliminary assessment of the global performance of the ITL procedure implemented using the three robotic platforms currently available.

Official Title
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Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow up Study

Conditions
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Hysterectomy

Intervention / Treatment
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* Procedure: Robotic-assisted hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective total laparoscopic hysterectomy surgery Age > 18 years Signature of the informed consent Exclusion Criteria: Patients undergoing emergency surgery Patients who are candidates for hysterectomy for a non-gynaecological indication Patients undergoing previous radiation therapy Patients unable to express adequate informed consent to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)<br>Women who undergo robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE) | Procedure: Robotic-assisted hysterectomy<br>* Robotic-assisted hysterectomy following usual surgical technique<br>|
| Robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)<br>Women who undergo robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM) | Procedure: Robotic-assisted hysterectomy<br>* Robotic-assisted hysterectomy following usual surgical technique<br>|
| Robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)<br>Women who undergo robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC) | Procedure: Robotic-assisted hysterectomy<br>* Robotic-assisted hysterectomy following usual surgical technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Textbook outcome satisfaction | Robotic-assisted hysterectomy performed without laparotomy conversion, intraoperative complications, postoperative complications (Clavien-Dindo classification ≥2), the performance of postoperative imaging excluding transvaginal ultrasound, reoperation, length of stay after day of surgery >2 days, readmission within 90 days, mortality, surgery length greater than 120 minutes, or intraoperative blood loss greater than 100mL. The Textbook outcome will be considered fulfilled if all conditions are met. | 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complications | Intraoperative complications graded based on the Clavien-Dindo classification | During surgery | 
| Postoperative complications | Postoperative complications graded based on the Clavien-Dindo classification | 30 and 90 days after surgery | 
| Operative time | Time between first incision and skin closure | During surgery | 
| Intraoperative blood loss | Total blood aspirate during the surgical procedure | During surgery | 
| Sexual function | The female sexual function index (FSFI) consists of 19 multiple-choice items that assess female sexual functioning based on 6 domains: desire, arousal, orgasm, pain, sexual satisfaction, and lubrication. The total score ranges from 0 to 36, with 26.55 as the cut-off suggesting the presence of sexual dysfunction. The higher the score, the better the sexual function. | 90 and 180 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysterectomy, Gynecologic pathology, Robotic-assisted laparoscopy