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

NCT03633786 · IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated 1 Feb 2022

What is being tested
standard laparoscopic surgery; robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms
For
Endometriosis
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 45 years. About 40 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 1 Sept 2018, ends 1 Jan 2024. Registered 16 Aug 2018.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT03633786

Sites

  • Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi HospitalBologna, BO, Italy