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Clinical Trials in Italy / NCT06781398
Starting soon Observational

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

NCT06781398 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2025-01
Last updated
2025-01-17

Condition(s) studied

Deep Endometriosis

Study 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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna
Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore Roma Roma

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

Radiological Diagnostics in Patients With Deep Endometriosis Recruiting
Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia Recruiting
An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program Recruiting
Phenotypic and Genotypic Characterisation of a Large, Multicentre Italian Cohort of 46, XY DSD Patients Recruiting
Multi-Dimensional Genomic Dissection of Ring Chromosome 14 Syndrome Active, not recruiting

Other trials for the same condition

Radiological Diagnostics in Patients With Deep Endometriosis Recruiting
Surgical TReatment of Women With Deep ENDometriosis Recruiting
Patients Undergoing Total Intracorporeal or Extracorporeal Anastomosis After Segmental Resection for Deep Endometriosis Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781398 on ClinicalTrials.gov ↗ ← All trials in Italy