Clinical trial NCT06781398: Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison
Official title: Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Compared
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Deep Endometriosis
Keywords: endometriosis
gynaecology
surgery
Da Vinci
HUGO RAS
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidates for surgery with minimally invasive approach for endometriosis

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: During surgery
Secondary outcomes:
measure: Conversion rate to laparoscopy or laparotomy
timeFrame: During surgery
measure: Intra-operative and post-operative complication rates; need for complication treatment
timeFrame: Perioperative and at 3 months
measure: Ergonomics for the surgeon
timeFrame: During surgery
measure: Entity of postoperative pain
timeFrame: Perioperative and at 3 and 12 months
measure: Hospitalization time
timeFrame: From the day of admission to the day of discharge, an average of 1 year
measure: Assessment of pain and quality of life
timeFrame: At 3 and 12 months after surgery
measure: Assessment of pain and quality of life
timeFrame: At 3 and 12 months after surgery
measure: Symptomatological and/or anatomical recurrence
timeFrame: At 12 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Diego Raimondo, MD
role: PRINCIPAL_INVESTIGATOR
References: