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

Registry ID
NCT06781398
Source registry
NCT
Status
NOT_YET_RECRUITING
Study type
OBSERVATIONAL
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
86
Start date
2025-01-01
Completion date
2027-10-01
Last update
2025-01-17

Conditions

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

Inclusion 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

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 \u002B surgical time) in the surgical treatment of patients with endometriosis","timeFrame":"During surgery"}]

Locations

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