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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate to laparoscopy or laparotomy | Conversion to laparoscopy or laparotomy, based on intraoperative assessment of the clinical picture | During surgery |
| Intra-operative and post-operative complication rates; need for complication treatment |
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Inclusion Criteria:
Exclusion Criteria:
- Past or current diagnosis of gynecologic oncologic pathology.
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Patients who are candidates for surgery with minimally invasive approach for endometriosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego Raimondo, MD | Contact | +393290636618 | die.raimondo@gmail.com | |
| Pierluigi Celerino, MD | Contact | celerinopierluigi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Diego Raimondo, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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)
| 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) | 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 | Perioperative and at 3 and 12 months |
| Hospitalization time | Hospitalization time | 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 | 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 | 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) | At 12 months after surgery |
| Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore | Roma | Roma | 00168 | Italy |
|
| D000091662 | Genital Diseases |