NCT06138197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

April 1, 2023

Last Update Submit

February 27, 2025

Conditions

Hysterectomy

Keywords

HysterectomyGynecologic pathologyRobotic-assisted laparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Intraoperative complications

    During surgery

  • Postoperative complications

    30 and 90 days after surgery

  • Operative time

    During surgery

  • Intraoperative blood loss

    During surgery

  • Sexual function

    90 and 180 days after surgery

Study Arms (3)

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 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 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

Interventions

Robotic-assisted hysterectomyPROCEDURE

Robotic-assisted hysterectomy following usual surgical technique

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All women undergoing robotic-assisted elective total laparoscopic hysterectomy

You may qualify if:

  • Patients undergoing elective total laparoscopic hysterectomy surgery
  • Age \> 18 years
  • Signature of the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, 37125, Italy

Location

Related Publications (5)

  • 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.

    PMID: 15039420BACKGROUND

  • 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.

    PMID: 26264829BACKGROUND

  • 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.

    PMID: 30985921BACKGROUND

  • 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.

    PMID: 35844092BACKGROUND

  • 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.

    PMID: 35373554BACKGROUND

Study Officials

  • Stefano Uccella, MD, PhD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

  • Simone Garzon, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

  • Pier Carlo Zorzato, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 1, 2023

First Posted

November 18, 2023

Study Start

January 4, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)