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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03633786
• Other study ID #: VINCENDO-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2022
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
Italy	Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery	Intraoperative
Secondary	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
Secondary	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
Secondary	Laparotomic conversion rate	Evaluation and comparison of laparotomic conversion rate in patients underwent standard laparoscopic or robot-assisted surgery	Intraoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complication rate	Comparison of standard laparoscopy and robot-assisted surgery concerning intraoperative complication rate in patients affected by deep infiltrating endometriosis	Intraoperative
Secondary	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