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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| Robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM) | Women who undergo robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM) |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted hysterectomy | Procedure | Robotic-assisted hysterectomy following usual surgical technique |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications | Intraoperative complications graded based on the Clavien-Dindo classification | During surgery |
| Postoperative complications | Postoperative complications graded based on the Clavien-Dindo classification |
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Inclusion Criteria:
Exclusion Criteria:
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All women undergoing robotic-assisted elective total laparoscopic hysterectomy
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUI Verona - University of Verona - Department of Obstetrics and Gynecology | Verona | 37125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15039420 | Background | 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. | |
| 26264829 | Background | 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. |
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| 30 and 90 days after surgery |
| Operative time | Time between first incision and skin closure | During surgery |
| Intraoperative blood loss | Total blood aspirate during the surgical procedure | 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. | 90 and 180 days after surgery |
| 30985921 | Background | 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. |
| 35844092 | Background | 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. |
| 35373554 | Background | 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. |
| 42268383 | Derived | 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 Jun 10. doi: 10.1007/s00464-026-12873-8. Online ahead of print. |