Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Active, not recruiting

Conditions: Endometriosis

Treatments: Procedure: robot-assisted surgery; Diagnostic Test: assessment of sexual function; Procedure: standard laparoscopic surgery; Diagnostic Test: assessment of bowel symptoms; Diagnostic Test: assessment of urinary symptoms

Study type: Interventional

Funder types: Other

Identifiers

NCT03633786

VINCENDO-01

Details and patient eligibility

About

Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often a cause of significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia and chronic pelvic pain) and infertility, drastically reducing patients' quality of life.

Surgical therapy with complete removal of endometriotic lesions is often necessary when the disease is resistant to medical therapy.

The minimally invasive surgical approach has proved to be the most advantageous.

Over time, there has been a growing use in the gynecological field of robot-assisted laparoscopic surgery.

Several clinical cases and retrospective studies on robotic surgery for DIE have highlighted favorable surgical outcomes, with the exception of operative times, compared to standard laparoscopic approach.

However, a randomized control studies comparing surgical outcomes and postoperative pelvic organs function in women with DIE submitted to robotic-assisted or conventional laparoscopy is missing.

In order to analyze the real impact of robotic advances the present study sought to assess surgical outcomes and urinary, bowel and sexual functions in women with DIE requiring minimally invasive surgery through robot-assisted or conventional lps approach.

Full description

Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.

Patients are divided into 2 groups:

Group A: standard laparoscopic approach

Group B: robot-assisted approach

After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance
• Patients with indication for removal of endometriosic lesions by standard and robot-assisted laparoscopy
• Obtaining Informed Consent

Exclusion criteria

• Contraindications for removal of endometriosic lesions by standard and robot-assisted laparoscopy
• Cardiovascular problems
• Hepatic insufficiency
• Psychiatric diseases
• History of oncologic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A: standard laparoscopic surgery

Other group

Description:

patients affected by deep infiltrating endometriosis undergoing standard laparoscopic surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms

Treatment:

Diagnostic Test: assessment of urinary symptoms

Diagnostic Test: assessment of bowel symptoms

Procedure: standard laparoscopic surgery

Diagnostic Test: assessment of sexual function

Group B: robot-assisted surgery

Other group

Description:

patients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms

Treatment:

Diagnostic Test: assessment of urinary symptoms

Diagnostic Test: assessment of bowel symptoms

Diagnostic Test: assessment of sexual function

Procedure: robot-assisted surgery