NCT03633786

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

4.3 years

First QC Date

August 9, 2018

Last Update Submit

January 18, 2022

Conditions

Endometriosis

Keywords

endometriosisrobot-assisted surgerystandard laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Evaluation and comparison of operative time in patients underwent standard laparoscopic or robot-assisted surgery

    Intraoperative

Secondary Outcomes (9)

  • Length of hospitalization

    Up to 4 days: from the date of surgery until the last day of hospitalization

  • Change of haemoglobin levels

    24 hours after surgery

  • Laparotomic conversion rate

    Intraoperative

  • Evaluation of sexual function

    up to three months after surgery

  • Evaluation of urinary symptoms

    up to three months after surgery

  • +4 more secondary outcomes

Study Arms (2)

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

Procedure: standard laparoscopic surgeryDiagnostic Test: assessment of sexual functionDiagnostic Test: assessment of bowel symptomsDiagnostic 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

Procedure: robot-assisted surgeryDiagnostic Test: assessment of sexual functionDiagnostic Test: assessment of bowel symptomsDiagnostic Test: assessment of urinary symptoms

Interventions

standard laparoscopic surgeryPROCEDURE

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

Group A: standard laparoscopic surgery
robot-assisted surgeryPROCEDURE

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.

Group B: robot-assisted surgery
assessment of sexual functionDIAGNOSTIC_TEST

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

Group A: standard laparoscopic surgeryGroup B: robot-assisted 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

Group A: standard laparoscopic surgeryGroup B: robot-assisted 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

Group A: standard laparoscopic surgeryGroup B: robot-assisted surgery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications for removal of endometriosic lesions by standard and robot-assisted laparoscopy
  • Cardiovascular problems
  • Hepatic insufficiency
  • Psychiatric diseases
  • History of oncologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, BO, 40138, Italy

Location

Related Publications (1)

  • 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.

    PMID: 33095458DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 16, 2018

Study Start

September 1, 2018

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

February 1, 2022

Record last verified: 2022-01

Locations

IT(1)