Comparison of Three Robotic Platforms for Hysterectomy

Completed

• Conditions: Hysterectomy
• Interventions: Procedure: Robotic-assisted hysterectomy

• Registration Number: NCT06138197
• Lead Sponsor: Universita di Verona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2024-01-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)	Robotic-assisted hysterectomy	Women who undergo robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)
Robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)	Robotic-assisted hysterectomy	Women who undergo robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)
Robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)	Robotic-assisted hysterectomy	Women who undergo robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)

Primary Outcome Measures

Name	Time	Method
Textbook outcome satisfaction	90 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	During surgery	Intraoperative complications graded based on the Clavien-Dindo classification
Operative time	During surgery	Time between first incision and skin closure
Intraoperative blood loss	During surgery	Total blood aspirate during the surgical procedure
Postoperative complications	30 and 90 days after surgery	Postoperative complications graded based on the Clavien-Dindo classification
Sexual function	90 and 180 days after surgery	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.

Trial Locations

Locations (1)

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology; 🇮🇹 Verona, Italy