Comparison of Three Robotic Platforms for Hysterectomy (COMPAR-HYST)

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

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Procedure: Robotic-assisted hysterectomy

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37125
    • AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All women undergoing robotic-assisted elective total laparoscopic hysterectomy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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
Operative time	Time between first incision and skin closure	During surgery
Intraoperative blood loss	Total blood aspirate during the surgical procedure	During surgery
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
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

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Stefano Uccella, MD, PhD, Universita di Verona; Principal Investigator: Simone Garzon, MD, Universita di Verona; Principal Investigator: Pier Carlo Zorzato, MD, Universita di Verona

Publications and helpful links

General Publications

• Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
• Torpy JM, Lynm C, Glass RM. JAMA patient page. Hysterectomy. JAMA. 2004 Mar 24;291(12):1526. doi: 10.1001/jama.291.12.1526. No abstract available.
• Lawrie TA, Liu H, Lu D, Dowswell T, Song H, Wang L, Shi G. Robot-assisted surgery in gynaecology. Cochrane Database Syst Rev. 2019 Apr 15;4(4):CD011422. doi: 10.1002/14651858.CD011422.pub2.
• Nobbenhuis MAE, Gul N, Barton-Smith P, O'Sullivan O, Moss E, Ind TEJ; Royal College of Obstetricians and Gynaecologists. Robotic surgery in gynaecology: Scientific Impact Paper No. 71 (July 2022). BJOG. 2023 Jan;130(1):e1-e8. doi: 10.1111/1471-0528.17242. Epub 2022 Jul 17.
• Monterossi G, Pedone Anchora L, Gueli Alletti S, Fagotti A, Fanfani F, Scambia G. The first European gynaecological procedure with the new surgical robot Hugo RAS. A total hysterectomy and salpingo-oophorectomy in a woman affected by BRCA-1 mutation. Facts Views Vis Obgyn. 2022 Mar;14(1):91-94. doi: 10.52054/FVVO.14.1.014.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 1, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Hysterectomy; Robotic-assisted laparoscopy; Gynecologic pathology
• Other Study ID Numbers: COMPAR-HYST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes