Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis
- Conditions
- Endometriosis
- Interventions
- Procedure: standard laparoscopic surgeryProcedure: robot-assisted surgeryDiagnostic Test: assessment of sexual functionDiagnostic Test: assessment of bowel symptomsDiagnostic Test: assessment of urinary symptoms
- Registration Number
- NCT03633786
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- 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
- Contraindications for removal of endometriosic lesions by standard and robot-assisted laparoscopy
- Cardiovascular problems
- Hepatic insufficiency
- Psychiatric diseases
- History of oncologic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: standard laparoscopic surgery standard laparoscopic surgery patients affected by deep infiltrating endometriosis undergoing standard laparoscopic surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Group B: robot-assisted surgery assessment of sexual function patients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Group B: robot-assisted surgery assessment of urinary symptoms patients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Group A: standard laparoscopic surgery assessment of sexual function patients affected by deep infiltrating endometriosis undergoing standard laparoscopic surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Group B: robot-assisted surgery assessment of bowel symptoms patients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Group A: standard laparoscopic surgery assessment of urinary symptoms patients affected by deep infiltrating endometriosis undergoing standard laparoscopic surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Group A: standard laparoscopic surgery assessment of bowel symptoms patients affected by deep infiltrating endometriosis undergoing standard laparoscopic surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Group B: robot-assisted surgery robot-assisted surgery patients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms
- Primary Outcome Measures
Name Time Method Operative time Intraoperative Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery
- Secondary Outcome Measures
Name Time Method Length of hospitalization Up to 4 days: from the date of surgery until the last day of hospitalization Evaluation and comparison of the length of hospitalization in patients underwent standard laparoscopic or robot-assisted surgery
Laparotomic conversion rate Intraoperative Evaluation and comparison of laparotomic conversion rate in patients underwent standard laparoscopic or robot-assisted surgery
Complication rate up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months Comparison of standard laparoscopy and robot-assisted surgery concerning complication rate in patients affected by deep infiltrating endometriosis, using Clavien-Dindo Classification.
Evaluation of sexual function up to three months after surgery Evaluation and comparison of sexual function in patients underwent standard laparoscopic or robot-assisted surgery before and after surgery, using the Female Sexual Function Index (FSFI). The FSFI is a validated questionnaire useful to measure sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials. The full scale score range goes from a minimum of 2.0 to a maximum of 36.0.
Evaluation of urinary symptoms up to three months after surgery Evaluation and comparison of urinary symptoms in patients underwent standard laparoscopic or robot-assisted surgery before and after surgery, using the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaire. It is a validated questionnaire with 3 subscale scores for incontinence symptoms (BFLUTS-IS) (range from 0 to 20), voiding symptoms (BFLUTS-VS) (range from 0 to 12), and filling symptoms (BFLUTS-FS) (range from 0 to 15), with the addition of single subscales for sexual function (BFLUTS-sex) (range from 0 to 6) and quality of life (BFLUTSQoL) (range from 0 to 18).
Change of haemoglobin levels 24 hours after surgery Evaluation and comparison of the change of haemoglobin levels in patients underwent standard laparoscopic or robot-assisted surgery
Evaluation of bowel symptoms up to three months after surgery Evaluation and comparison of bowel symptoms in patients underwent standard laparoscopic or robot-assisted surgery before and after surgery, using the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS). The KESS is a validated questionnaire for diagnosis of constipation. KESS has an added advantage of differentiating between various subtypes of constipation. Total scores can range from 0 (no symptoms) to 39 (high symptom severity). A cut-off score of \> 11 indicates constipation.
Evaluation of disease recurrence rate 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 Evaluation and comparison of disease recurrence rate in patients underwent standard laparoscopic or robot-assisted surgery before and after surgery.
Endometriosis recurrence can have different levels: symptoms recurrence based on patient history (VAS pain score ≥ 5), but no proof of recurrence by imaging and/or surgery; endometriosis recurrence based on non-invasive imaging in patients with or without symptoms; recurrence of histologically proven endometriosis: when the patient is re-operated, endometriosis is visually observed and confirmed histologically.
Trial Locations
- Locations (1)
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
🇮🇹Bologna, BO, Italy