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

NCT06781398 | Not Yet Recruiting

• 1 other identifier: ROBOTENDO
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 2

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

Conditions

Deep Endometriosis

Keywords

endometriosis; gynaecology; surgery; Da Vinci; HUGO RAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Conversion rate to laparoscopy or laparotomy

  During surgery

• Intra-operative and post-operative complication rates; need for complication treatment

  Perioperative and at 3 months

• Ergonomics for the surgeon

  During surgery

• Entity of postoperative pain

  Perioperative and at 3 and 12 months

• Hospitalization time

  From the day of admission to the day of discharge, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Past or current diagnosis of gynecologic oncologic pathology.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore

Roma, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Diego Raimondo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Raimondo, MD

CONTACT

+393290636618; die.raimondo@gmail.com

Pierluigi Celerino, MD

CONTACT

celerinopierluigi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 17, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 17, 2025

Record last verified: 2024-10

Locations

IT (2)