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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: standard laparoscopic surgery
* Procedure: robot-assisted surgery
* Diagnostic Test: assessment of sexual function
* Diagnostic Test: assessment of bowel symptoms
* Diagnostic Test: assessment of urinary symptoms


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: standard laparoscopic surgery<br>patients affected by deep infiltrating endometriosis undergoing standard laparoscopic surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms | Procedure: standard laparoscopic surgery<br>* removal of endometriotic lesions with laparoscopic instruments (KARL STORZ Gesellschaft mit beschränkter Haftung & Co., Tuttlingen, Germany) using 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm<br>Diagnostic Test: assessment of sexual function<br>* assessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery<br>Diagnostic Test: assessment of bowel symptoms<br>* assessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery<br>Diagnostic Test: assessment of urinary symptoms<br>* assessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery<br>|
| Other: Group B: robot-assisted surgery<br>patients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms | Procedure: robot-assisted surgery<br>* removal of endometriotic lesions with da Vinci Xi robotic system (Intuitive Surgical Inc., Sunnyvale, CA, USA), using 5 transperitoneal abdominal accesses and trocars from 8 and 12 mm. The robotic mechanical arms are associated with the 8 mm abdominal trocars to allow intervention by the first operator, with the aid of a surgical console.<br>Diagnostic Test: assessment of sexual function<br>* assessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery<br>Diagnostic Test: assessment of bowel symptoms<br>* assessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery<br>Diagnostic Test: assessment of urinary symptoms<br>* assessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | Evaluation and comparison of the length of hospitalization in patients underwent standard laparoscopic or robot-assisted surgery | Up to 4 days: from the date of surgery until the last day of hospitalization | 
| Change of haemoglobin levels | Evaluation and comparison of the change of haemoglobin levels in patients underwent standard laparoscopic or robot-assisted surgery | 24 hours after surgery | 
| Laparotomic conversion rate | Evaluation and comparison of laparotomic conversion rate in patients underwent standard laparoscopic or robot-assisted surgery | Intraoperative | 
| Evaluation of sexual function | 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. | up to three months after surgery | 
| Evaluation of urinary symptoms | 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). | up to three months after surgery | 
| Evaluation of bowel symptoms | 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. | up to three months after surgery | 
| Evaluation of disease recurrence rate | 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. | 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 | 
| Complication rate | Comparison of standard laparoscopy and robot-assisted surgery concerning intraoperative complication rate in patients affected by deep infiltrating endometriosis | Intraoperative | 
| Complication rate | Comparison of standard laparoscopy and robot-assisted surgery concerning complication rate in patients affected by deep infiltrating endometriosis, using Clavien-Dindo Classification. | up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, robot-assisted surgery, standard laparoscopic surgery