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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Endometriosis

Detailed 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

• Study Type: Observational
• Enrollment (Estimated): 86

Contacts and Locations

• Study Contact: Name: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com
• Study Contact Backup: Name: Pierluigi Celerino, MD; Email: celerinopierluigi@gmail.com

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com
    • Contact: Pierluigi Celerino, MD; Email: celerinopierluigi@gmail.com
    • Contact: Diego Raimondo, MD
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore
    • Contact: Federica Campolo, MD; Phone Number: +390630155629; Email: campolo.f@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are candidates for surgery with minimally invasive approach for endometriosis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Diego Raimondo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: surgery; endometriosis; Da Vinci; gynaecology; HUGO RAS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: ROBOTENDO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No