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

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ClinicalTrials.gov Identifier: NCT03633786
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Mabrouk, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.


Condition or disease Intervention/treatment Phase
Endometriosis 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 Not Applicable

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.

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Study Type : Interventional
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Group A: 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
Procedure: standard laparoscopic surgery
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

Diagnostic Test: assessment of sexual function
assessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery

Diagnostic Test: assessment of bowel symptoms
assessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery

Diagnostic Test: assessment of urinary symptoms
assessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery

Group B: 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
Procedure: robot-assisted surgery

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.


Diagnostic Test: assessment of sexual function
assessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery

Diagnostic Test: assessment of bowel symptoms
assessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery

Diagnostic Test: assessment of urinary symptoms
assessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery




Primary Outcome Measures :
  1. Operative time [ Time Frame: Intraoperative ]
    Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery


Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: 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

  2. Change of haemoglobin levels [ Time Frame: 24 hours after surgery ]
    Evaluation and comparison of the change of haemoglobin levels in patients underwent standard laparoscopic or robot-assisted surgery

  3. Laparotomic conversion rate [ Time Frame: Intraoperative ]
    Evaluation and comparison of laparotomic conversion rate in patients underwent standard laparoscopic or robot-assisted surgery

  4. Evaluation of sexual function [ Time Frame: 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.

  5. Evaluation of urinary symptoms [ Time Frame: 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).

  6. Evaluation of bowel symptoms [ Time Frame: 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.

  7. Evaluation of disease recurrence rate [ Time Frame: 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.


  8. Complication rate [ Time Frame: Intraoperative ]
    Comparison of standard laparoscopy and robot-assisted surgery concerning intraoperative complication rate in patients affected by deep infiltrating endometriosis, using Clavien-Dindo Classification.

  9. Complication rate [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633786


Contacts
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Contact: Diego Raimondo 00390512144385 die.raimondo@gmail.com

Locations
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Italy
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital Recruiting
Bologna, BO, Italy, 40138
Contact: Diego Raimondo    00390512144385    die.raimondo@gmail.com   
Principal Investigator: Mohamed Mabrouk         
Principal Investigator: Renato Seracchioli         
Principal Investigator: Diego Raimondo         
Sub-Investigator: Alessandro Arena         
Sub-Investigator: Raffaella Iodice         
Sub-Investigator: Manuela Mastronardi         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
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Responsible Party: Mohamed Mabrouk, Principal Investigator, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03633786    
Other Study ID Numbers: VINCENDO-01
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Mabrouk, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
endometriosis
robot-assisted surgery
standard laparoscopic surgery
Additional relevant MeSH terms:
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Endometriosis