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

Summary

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.

Conditions

• Endometriosis

Interventions

PROCEDURE

standard laparoscopic surgery

removal of endometriotic lesions with laparoscopic instruments (KARL STORZ Gesellschaft mit beschränkter Haftung \& Co., Tuttlingen, Germany) using 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm

PROCEDURE

robot-assisted surgery

removal of endometriotic lesions with da Vinci Xi robotic system (Intuitive Surgical Inc., Sunnyvale, CA, USA), using 5 transperitoneal abdominal accesses and trocars from 8 and 12 mm. The robotic mechanical arms are associated with the 8 mm abdominal trocars to allow intervention by the first operator, with the aid of a surgical console.

DIAGNOSTIC_TEST

assessment of sexual function

assessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery

DIAGNOSTIC_TEST

assessment of bowel symptoms

assessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery

DIAGNOSTIC_TEST

assessment of urinary symptoms

assessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2023-01-01

Completion

2024-01-01

Countries

• Italy

Study Locations