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Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis (ECHOENDO)

Primary Purpose

Endometriosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovaginal ultrasound
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring deep pelvic endometriosis, rectal shaving segmental digestive resection, endovaginal ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years
  • Deep pelvic endometriosis with symptomatic rectal involvement
  • With surgical indication of rectal shaving validated in "RCP" or during the pre-operative consultation by the surgeon

Exclusion Criteria:

  • History of inflammatory digestive pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving)
    if endovaginal ultrasound performed in the operating room (before or after shaving) modifies the choice of surgical technique in at least 2 cases out of 10, the value of endovaginal ultrasound in the operating room in the management of rectal damage by shaving will be validated

    Secondary Outcome Measures

    anatomo-pathological analysis of the operating piece.
    The anatomo-pathological data will be available if the choice of surgical technique is modified following one of the endovaginal ultrasound scans carried out in the operating theatre - and therefore if a discoid or segmental resection is carried out. By confirming damage to the rectal mucosa and/or stenosis of the digestive lumen, these anatomo-pathological analyses will make it possible to validate the questioning of the choice of surgical technique. This information is thus complementary to the main evaluation criterion, by providing an external validity criterion.

    Full Information

    First Posted
    August 9, 2022
    Last Updated
    August 11, 2022
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05499884
    Brief Title
    Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis
    Acronym
    ECHOENDO
    Official Title
    Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The protocol of this study consists in the inclusion of patients with endometriosic rectal involvement with a scheduled intervention. An endovaginal ultrasound will be performed in the operating room by the radiology team to confirm the operative indication of rectal shaving then in a second step a second ultrasound in the operating room will confirm the complete excision of the lesion or the case will allow to perform a more complete gesture (discoid or segmental resection) if the shaving is not sufficient with ultrasound and / or macroscopically

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometriosis
    Keywords
    deep pelvic endometriosis, rectal shaving segmental digestive resection, endovaginal ultrasound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Endovaginal ultrasound
    Intervention Description
    Endovaginal ultrasound will be performed in the operating room by the radiology team to: to confirm the operative indication for a rectal shaving ; to confirm the complete removal of the lesion
    Primary Outcome Measure Information:
    Title
    Questioning the choice of surgical technique (performing a more complete procedure, such as discoid or segmental resection, immediately or after shaving)
    Description
    if endovaginal ultrasound performed in the operating room (before or after shaving) modifies the choice of surgical technique in at least 2 cases out of 10, the value of endovaginal ultrasound in the operating room in the management of rectal damage by shaving will be validated
    Time Frame
    during the procedure/surgery
    Secondary Outcome Measure Information:
    Title
    anatomo-pathological analysis of the operating piece.
    Description
    The anatomo-pathological data will be available if the choice of surgical technique is modified following one of the endovaginal ultrasound scans carried out in the operating theatre - and therefore if a discoid or segmental resection is carried out. By confirming damage to the rectal mucosa and/or stenosis of the digestive lumen, these anatomo-pathological analyses will make it possible to validate the questioning of the choice of surgical technique. This information is thus complementary to the main evaluation criterion, by providing an external validity criterion.
    Time Frame
    during the procedure/surgery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Patients with scheduled surgery for pelvic endometriosis with rectal involvement
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years Deep pelvic endometriosis with symptomatic rectal involvement With surgical indication of rectal shaving validated in "RCP" or during the pre-operative consultation by the surgeon Exclusion Criteria: History of inflammatory digestive pathology
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chrystele RUBOD, MD,PhD
    Phone
    0320445962
    Email
    chrystele.rubod@chru-lille.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chrystele RUBOD, MD,PhD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Feasibility and Potential Aids of Intra-operative Endo-vaginal Ultrasound When Performing Rectal Shaving for Endometriosis

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