Comparison of Three Robotic Platforms for Hysterectomy (COMPAR-HYST)

University of Verona

Status: Completed

Conditions: Hysterectomy

Treatments: Procedure: Robotic-assisted hysterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06138197

COMPAR-HYST

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)

Description:

Women who undergo robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)

Treatment:

Procedure: Robotic-assisted hysterectomy

Robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)

Description:

Women who undergo robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)

Treatment:

Procedure: Robotic-assisted hysterectomy

Robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)

Description:

Women who undergo robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)

Treatment:

Procedure: Robotic-assisted hysterectomy