HysterectomyCOMPAR-HYSTNCT06138197
Comparison of Three Robotic Platforms for Hysterectomy
An observational study of Hysterectomy, run by Universita di Verona at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Robotic-assisted hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women undergoing robotic-assisted elective total laparoscopic hysterectomy
Who may be able to join
- Patients undergoing elective total laparoscopic hysterectomy surgery
- Age > 18 years
- Signature of the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125
About this study
Official title: 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.
- Conditions
- Hysterectomy
- Being tested
- Robotic-assisted hysterectomy
- Keywords
- Hysterectomy, Gynecologic pathology, Robotic-assisted laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted hysterectomyProcedure or surgery
Robotic-assisted hysterectomy following usual surgical technique
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Procedure: Robotic-assisted hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after surgery
Secondary outcomes (5)
Intraoperative complications
Intraoperative complications graded based on the Clavien-Dindo classification
Measured: During surgery
Postoperative complications
Postoperative complications graded based on the Clavien-Dindo classification
Measured: 30 and 90 days after surgery
Operative time
Time between first incision and skin closure
Measured: During surgery
Intraoperative blood loss
Total blood aspirate during the surgical procedure
Measured: 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.
Measured: 90 and 180 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start4 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Uccella, Universita di Verona
- Investigators
- Stefano Uccella, MD, PhD, Principal investigator, Universita di VeronaSimone Garzon, MD, Principal investigator, Universita di VeronaPier Carlo Zorzato, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138197
- Sponsor's protocol ID
- COMPAR-HYST
- Acronym
- COMPAR-HYST
- Status last verified
- Feb 2025
- First submitted
- 1 Apr 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15039420Aarts 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.
PubMed 26264829Lawrie 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.
PubMed 30985921Nobbenhuis 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.
PubMed 35844092Monterossi 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.
PubMed 35373554Garzon 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.
PubMed 42268383
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow Up Study
- ClinicalTrials.gov ID
- NCT06138197
- Acronym / sponsor ID
- COMPAR-HYST / COMPAR-HYST
- Conditions
- Hysterectomy
- Keywords
- Hysterectomy, Gynecologic pathology, Robotic-assisted laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE) | – | Procedure: Robotic-assisted hysterectomyWomen who undergo robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE) |
| Robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM) | – | Procedure: Robotic-assisted hysterectomyWomen who undergo robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM) |
| Robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC) | – | Procedure: Robotic-assisted hysterectomyWomen who undergo robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women undergoing robotic-assisted elective total laparoscopic hysterectomy
Key inclusion criteria (3 listed)
- Patients undergoing elective total laparoscopic hysterectomy surgery
- Age > 18 years
- Signature of the informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted hysterectomyRobotic-assisted hysterectomy following usual surgical technique | Procedure or surgery | 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) |
Primary outcome
Textbook outcome satisfaction
Time frame: 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.
5 secondary outcomes
Intraoperative complications
Time frame: During surgery
Postoperative complications
Time frame: 30 and 90 days after surgery
Operative time
Time frame: During surgery
Intraoperative blood loss
Time frame: During surgery
Sexual function
Time frame: 90 and 180 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 15039420Torpy 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.
- Background: PubMed 26264829Aarts 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.
- Background: PubMed 30985921Lawrie 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.
- Background: PubMed 35844092Nobbenhuis 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.
- Background: PubMed 35373554Monterossi 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.
- Derived from this study: PubMed 42268383Garzon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Uccella, MD, PhD principal investigator
Universita di Verona
Simone Garzon, MD principal investigator
Universita di Verona
Pier Carlo Zorzato, MD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Textbook outcome satisfaction (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138197, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.