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

Not yet recruiting

• Conditions: Deep Endometriosis

• Registration Number: NCT06781398
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2027-07
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	During surgery	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 Outcome Measures

Name	Time	Method
Conversion rate to laparoscopy or laparotomy	During surgery	Conversion to laparoscopy or laparotomy, based on intraoperative assessment of the clinical picture
Intra-operative and post-operative complication rates; need for complication treatment	Perioperative and at 3 months	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	During surgery	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	Perioperative and at 3 and 12 months	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
Hospitalization time	From the day of admission to the day of discharge, an average of 1 year	Hospitalization time
Assessment of pain and quality of life	At 3 and 12 months after surgery	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
Symptomatological and/or anatomical recurrence	At 12 months after surgery	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)

Trial Locations

Locations (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore; 🇮🇹 Roma, Italy