An observational study in Deep Endometriosis, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Not yet recruiting at 2 sites in Italy. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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
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
925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.
This study's planned enrollment of 86 is below the median of 125 across 354 observational studies indexed under Endometriosis.
Browse Endometriosis studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 509 studies on the registry; 285 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who are candidates for surgery with minimally invasive approach for endometriosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Past or current diagnosis of gynecologic oncologic pathology.
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
Conversion rate to laparoscopy or laparotomy
Conversion to laparoscopy or laparotomy, based on intraoperative assessment of the clinical picture
Time frame: During surgery
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
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
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
Hospitalization time
Hospitalization time
Time frame: From the day of admission to the day of discharge, an average of 1 year
Assessment of pain and quality of life
Pain assessment and change in quality of life, assessed by administration of NRS scale, from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable' respectively
Time frame: At 3 and 12 months after surgery
Assessment of pain and quality of life
Pain assessment and change in quality of life, assessed by administration of quality of life questionnaire (EHP-30, Endometriosis-related health profile), scored from 0 to 100, with 0 being the best outcome and 100 the worst outcome
Time frame: At 3 and 12 months after surgery
Symptomatological and/or anatomical recurrence
Clinical or anatomical resumption of disease by gynecological examination, recent pathological history, pelvic ultrasound, and possible radiological methods such as nuclear magnetic resonance imaging (NMR)
Time frame: At 12 months after surgery
Start is estimated for Jan 2025; primary completion for Jul 2027, 30 months later.
Of 153 non-industry observational studies under Endometriosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 30 months is close to that.
Counting every sponsor, half of 182 studies reached it within 30 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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