Hysterectomy
Conditions
Keywords
Hysterectomy, Gynecologic pathology, Robotic-assisted laparoscopy
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.
Interventions
PROCEDURERobotic-assisted hysterectomy
Robotic-assisted hysterectomy following usual surgical technique
Sponsors
Universita di Verona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective total laparoscopic hysterectomy surgery * Age \> 18 years * Signature of the informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Textbook outcome satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative complications | During surgery | Intraoperative complications graded based on the Clavien-Dindo classification |
| Postoperative complications | 30 and 90 days after surgery | Postoperative complications graded based on the Clavien-Dindo classification |
| Operative time | During surgery | Time between first incision and skin closure |
| Intraoperative blood loss | During surgery | Total blood aspirate during the surgical procedure |
| Sexual function | 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. |
Countries
Italy
Outcome results
None listed