COMPAR-HYST
Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow Up Study
Sponsor study identifier
observational
150
1 country
1
Study Start
January 4, 2024
Actual (reported)Primary Completion
December 31, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2023
Actual (reported)November 18, 2023
Actual (reported)January 4, 2024
Actual (reported)December 31, 2024
Actual (reported)December 31, 2024
Actual (reported)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
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
Women who undergo robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)
Women who undergo robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)
Women who undergo robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)
Robotic-assisted hysterectomy following usual surgical technique
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All women undergoing robotic-assisted elective total laparoscopic hysterectomy
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125, Italy
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.
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.
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.
Stefano Uccella, MD, PhD
Universita di Verona
Simone Garzon, MD
Universita di Verona
Pier Carlo Zorzato, MD
Universita di Verona
150 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2023
First Posted
November 18, 2023
Study Start
January 4, 2024
Actual (reported)Long-term Outcomes After Laparoscopic Subtotal and Total Hysterectomy
Contact the study team to confirm eligibility.
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.
Garzon S, Landi S, Da Ros A, Zorzato PC, Festi A, Del Prete B, Galli L, Sartori F, Bosco M, Bergamini V, Scarperi S, Giacopuzzi S, Polati E, Bravi CM, Leardini C, Uccella S. Da Vinci(R) X, Versius(R), and Hugo RAS in minimally invasive robotic-assisted hysterectomy: the COMPAR-HYST prospective study. Surg Endosc. 2026 Aug;40(8):6687-6695. doi: 10.1007/s00464-026-12873-8. Epub 2026 Jun 10.
Primary Completion
December 31, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
March 4, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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