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

  • STATUS
    Recruiting
  • End date
    Nov 25, 2021
  • participants needed
    40
  • sponsor
    Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Updated on 25 January 2021
laparoscopic surgery
laparoscopy
dysmenorrhea
pelvic pain
endometriosis
dyspareunia
infertility
urinary symptoms
dysuria
deep endometriosis
robot-assisted surgery

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.

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.

Details
Condition Endometriosis, Female Genital Diseases, Gynecological Infections
Treatment robot-assisted surgery, standard laparoscopic surgery, assessment of sexual function, assessment of bowel symptoms, assessment of urinary symptoms
Clinical Study IdentifierNCT03633786
SponsorAzienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Are you female?
Do you have any of these conditions: Endometriosis or Gynecological Infections or Female Genital Diseases?
Do you have any of these conditions: Female Genital Diseases or Gynecological Infections or Endometriosis?
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
Clear my responses

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