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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
During surgery

Secondary outcomes

1

Conversion rate to laparoscopy or laparotomy

Conversion to laparoscopy or laparotomy, based on intraoperative assessment of the clinical picture

Time frame
During surgery
2

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)

Time frame
Perioperative and at 3 months
3

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)

Time frame
During surgery
4

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

Time frame
Perioperative and at 3 and 12 months

Other outcomes

Sponsors and contacts

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