AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125, Italy
NCT Number: NCT06138197
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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Notify Me18 year and older
Female
Observational
Verona, 37125, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Robotic-assisted hysterectomy following usual surgical technique
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.
Time frame: During surgery
Intraoperative complications graded based on the Clavien-Dindo classification
Time frame: 30 and 90 days after surgery
Postoperative complications graded based on the Clavien-Dindo classification
Time frame: During surgery
Time between first incision and skin closure
Time frame: During surgery
Total blood aspirate during the surgical procedure
Time frame: 90 and 180 days after surgery
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.
Universita di Verona
Other
Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow Up Study
Acronym: COMPAR-HYST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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