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Conventional Laparoscopy Versus Robotic Surgery for Pain Relief in Patients With Deep Infiltrating Endometriosis

NCT05362838 · Medical University of Vienna · Updated 8 June 2022

What is being tested
robotic-assisted laparoscopy; Conventional laparoscopy
For
Endometriosis; Endometriosis-related Pain; Endometriosis Pelvic
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 51 years. About 50 people. The full rules are on the registry page.
Where
Austria
When
Starts or started 1 April 2022, ends 31 Dec 2023. Registered 5 May 2022.
Results
None posted yet.

In the researchers' words

Background: Endometriosis is a common disease, affecting women in their reproductive age suffering from infertility, adnexal masses and chronic pelvic pain, obstruction of the bowel or urinary tract. Deeply infiltrating endometriosis (DIE) is defined as a solid endometriosis mass situated more than 5 mm deep to the peritoneum. These lesions are considered very active and are strongly associated with pelvic pain symptoms. Surgery is recommended in women with pain resistant to medical therapy and in women with contraindications to or refusal of medical therapy. Further indications for surgical treatment are the need of excluding malignancy in an adnexal mass, obstruction of the bowel or urinary tract. It is hypothesized that in patients with lesions in complex anatomic sites, a robot-assisted approach may provide improved instrument articulation compared with conventional laparoscopy, but no data are available. Aims: The aim of this study is to perform a pilot study investigating differences between robot-assisted laparoscopy compared to conventional laparoscopy regarding subjective symptom outcome, evaluated by VAS score for non-menstrual pelvic pain and dysmenorrhea. Study population: The study population will consist of women aged between 18 and 51 years who are referred to our gynecologic outpatient clinic due to symptomatic endometriosis. Women with suggested DIE and an…
ClinicalTrials.gov, NCT05362838

Sites

  • Medical University of Vienna, Department of Obstetrics and GynecologyVienna, Austria