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

January 18, 2022 updated by: Renato Seracchioli, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: 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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Intraoperative
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
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
Up to 4 days: from the date of surgery until the last day of hospitalization
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
24 hours after surgery
Laparotomic conversion rate
Time Frame: Intraoperative
Evaluation and comparison of laparotomic conversion rate in patients underwent standard laparoscopic or robot-assisted surgery
Intraoperative
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.
up to three months after surgery
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).
up to three months after surgery
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.
up to three months after surgery
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.
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
Time Frame: Intraoperative
Comparison of standard laparoscopy and robot-assisted surgery concerning intraoperative complication rate in patients affected by deep infiltrating endometriosis
Intraoperative
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.
up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (ACTUAL)

August 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VINCENDO-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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