Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Not yet enrolling

Conditions: Deep Endometriosis

Study type: Observational

Funder types: Other

Identifiers

NCT06781398

ROBOTENDO

Details and patient eligibility

About

The aim is to clarify whether both surgical approaches represent, equivalently, a good treatment for the management of patients with deep endometriosis who are candidates for surgery, or whether there are any differences between the two methods, and, if so, how they differ

Full description

Numerous studies have shown how surgical excision of deep endometriosis nodules improves pain and quality of life. Robotic-assisted laparoscopic surgery has been employed for the treatment of deep endometriosis. While the Da Vinci System is widely used for the surgical treatment of endometriosis, with good results, the available data regarding the benefits of the HUGO RAS System, however, are limited, given the recent introduction of this method in gynecology, and particularly in the treatment of endometriosis. The aim of the study is to investigate whether the robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis

Enrollment: 86 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 55 years;
• Pelvic ultrasound and/or radiologic (MRI/CT scan with rectal insufflation) diagnosis of endometriosis
• Indication for surgery (symptomatic despite or refractory to medical therapy, and/or with critical bowel stenosis or urinary stenosis, and/or infertile awaiting medically assisted procreation (PMA) treatment or with previous failed assisted fertilization attempts);
• ASA (American Society of Anesthesiologists physical status classification) class between 1 and 3;
• Acquisition of consent to undergo surgical treatment;
• Acquisition of consent for study participation and data processing

Exclusion criteria

• Past or current diagnosis of gynecologic oncologic pathology.