Clinical trial NCT03633786: Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis
Official title: Evaluation of Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
robot-assisted surgery
standard laparoscopic surgery
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time
timeFrame: Intraoperative
Secondary outcomes:
measure: Length of hospitalization
timeFrame: Up to 4 days: from the date of surgery until the last day of hospitalization
measure: Change of haemoglobin levels
timeFrame: 24 hours after surgery
measure: Laparotomic conversion rate
timeFrame: Intraoperative
measure: Evaluation of sexual function
timeFrame: up to three months after surgery
measure: Evaluation of urinary symptoms
timeFrame: up to three months after surgery
measure: Evaluation of bowel symptoms
timeFrame: up to three months after surgery
measure: Evaluation of disease recurrence rate
timeFrame: Up to 12 months after surgery; from date of surgery until the date of first clinical or trans-vaginal/abdominal ultrasound documented recurrence, assessed up to 12 months
measure: Complication rate
timeFrame: Intraoperative
measure: Complication rate
timeFrame: up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
state: BO
Study officials:
References:
citation: Bafort C, Beebeejaun Y, Tomassetti C, Bosteels J, Duffy JM. Laparoscopic surgery for endometriosis. Cochrane Database Syst Rev. 2020 Oct 23;10(10):CD011031. doi: 10.1002/14651858.CD011031.pub3.