Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow Up Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universita di Verona
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Textbook outcome satisfaction
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Operative time(During surgery)
- Intraoperative complications(During surgery)
- Intraoperative blood loss(During surgery)
- Postoperative complications(30 and 90 days after surgery)
- Sexual function(90 and 180 days after surgery)
Investigators
Stefano Uccella
Clinical Professor
Universita di Verona