EndometriosisNCT03633786
Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis
A study testing standard laparoscopic surgery, robot-assisted surgery and assessment of sexual function in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- standard laparoscopic surgery, robot-assisted surgery and assessment of sexual function
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Contraindications for removal of endometriosic lesions by standard and robot-assisted laparoscopy
- Cardiovascular problems
- Hepatic insufficiency
- Psychiatric diseases
- History of oncologic disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, BO, 40138
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- standard laparoscopic surgery, robot-assisted surgery, assessment of sexual function, assessment of bowel symptoms, assessment of urinary symptoms
- Keywords
- endometriosis, robot-assisted surgery, standard laparoscopic surgery
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard laparoscopic surgeryProcedure or 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
robot-assisted surgeryProcedure or 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.
assessment of sexual functionDiagnostic test
assessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery
assessment of bowel symptomsDiagnostic test
assessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery
assessment of urinary symptomsDiagnostic test
assessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A: standard laparoscopic surgery | Other | patients affected by deep infiltrating endometriosis undergoing standard laparoscopic surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Receives: Procedure: standard laparoscopic surgery; Diagnostic Test: assessment of sexual function; Diagnostic Test: assessment of bowel symptoms; Diagnostic Test: assessment of urinary symptoms |
| Group B: robot-assisted surgery | Other | patients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms Receives: Procedure: robot-assisted surgery; Diagnostic Test: assessment of sexual function; Diagnostic Test: assessment of bowel symptoms; Diagnostic Test: assessment of urinary symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery
Measured: Intraoperative
Secondary outcomes (9)
Length of hospitalization
Evaluation and comparison of the length of hospitalization in patients underwent standard laparoscopic or robot-assisted surgery
Measured: 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
Measured: 24 hours after surgery
Laparotomic conversion rate
Evaluation and comparison of laparotomic conversion rate in patients underwent standard laparoscopic or robot-assisted surgery
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Seracchioli, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633786
- Sponsor's protocol ID
- VINCENDO-01
- Status last verified
- Jan 2022
- First submitted
- 9 Aug 2018
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33095458
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Robot-assisted Versus Standard Laparoscopic Approach for the Surgical Treatment of Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT03633786
- Acronym / sponsor ID
- VINCENDO-01
- Conditions
- Endometriosis
- Keywords
- endometriosis, robot-assisted surgery, standard laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: standard laparoscopic surgery | Other | Procedure: standard laparoscopic surgery, Diagnostic Test: assessment of sexual function, Diagnostic Test: assessment of bowel symptoms, Diagnostic Test: assessment of urinary symptomspatients 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 | Other | Procedure: robot-assisted surgery, Diagnostic Test: assessment of sexual function, Diagnostic Test: assessment of bowel symptoms, Diagnostic Test: assessment of urinary symptomspatients affected by deep infiltrating endometriosis undergoing robot-assisted surgery; assessment of sexual function; assessment of bowel symptoms; assessment of urinary symptoms |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Contraindications for removal of endometriosic lesions by standard and robot-assisted laparoscopy
- Cardiovascular problems
- Hepatic insufficiency
- Psychiatric diseases
- History of oncologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard laparoscopic surgeryremoval 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 | Procedure or surgery | Group A: standard laparoscopic surgery |
| robot-assisted surgeryremoval 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. | Procedure or surgery | Group B: robot-assisted surgery |
| assessment of sexual functionassessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery | Diagnostic test | Group A: standard laparoscopic surgery, Group B: robot-assisted surgery |
| assessment of bowel symptomsassessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery | Diagnostic test | Group A: standard laparoscopic surgery, Group B: robot-assisted surgery |
| assessment of urinary symptomsassessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery | Diagnostic test | Group A: standard laparoscopic surgery, Group B: robot-assisted surgery |
Primary outcome
Operative time
Time frame: Intraoperative
Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery
9 secondary outcomes
Length of hospitalization
Time frame: 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
Laparotomic conversion rate
Time frame: Intraoperative
Evaluation of sexual function
Time frame: up to three months after surgery
Evaluation of urinary symptoms
Time frame: up to three months after surgery
Evaluation of bowel symptoms
Time frame: 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
Complication rate
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 33095458Bafort 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard laparoscopic surgery, robot-assisted surgery and assessment of sexual function in people with Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03633786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.