About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial population
Patients who are candidates for surgery with minimally invasive approach for endometriosis
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Compare the two surgical techniques by evaluating the operative time (expressed in minutes), which includes docking and surgical time. Docking is defined as the time required to move the robotic arms into the operative field, place them in their respective port sites, and insert the robotic instruments into the abdomen. Surgical time is from the end of docking to suturing the laparoscopic/laparotomy breaches.
Secondary outcomes
Conversion rate to laparoscopy or laparotomy
Conversion to laparoscopy or laparotomy, based on intraoperative assessment of the clinical picture
Intra-operative and post-operative complication rates; need for complication treatment
Intraoperative complications (incidental injury to organs and structures, incoercible bleeding) classified by ClassIntra System (iAE); postoperative complications (anemia, postoperative fever, hemoperitoneum, bowel perforation), according to Clavien-Dindo classification; treatment of complications (GRC transfusion, reintervention, interventional procedures)
Ergonomics for the surgeon
Ergonomics of the two robotic approaches established through the Rapid Upper Limb Assessment (RULA) system that allows through the compilation of a score, rapid assessment of the load on the neck and upper limb. The risk of work-related disorders is calculated in a score from 1 (low) to 7 (high)
Entity of postoperative pain
Postoperative pain assessed as maximum value recorded by numeric rating scale (NRS), from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable' respectively
Sponsors and contacts
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