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Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias (ROCSTAR)

Primary Purpose

Ventral Incisional Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Component separation (transversus abdominis release)
Sponsored by
Algemeen Ziekenhuis Maria Middelares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Incisional Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- All patients with a ventral incisional hernia of more than 8 centimeters in width

Exclusion Criteria:

  • Emergency surgery
  • Pregnancy
  • Age<18
  • Incisional hernia repair after open abdomen or enterocutaneous fistula
  • Active wound infection
  • Previous anterior or posterior component separation
  • Absence of a signed informed consent
  • Patients unable to give informed consent or complete the quality-of-life assessment (due to language barriers or intellectual capacity)
  • Primary ventral hernias

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Robotic-assisted repair of wide ventral incisional hernia

    Open repair of wide ventral incisional hernia

    Arm Description

    Robotic

    Open

    Outcomes

    Primary Outcome Measures

    Length of postoperative hospital stay
    Length of postoperative hospital stay

    Secondary Outcome Measures

    Skin-to-skin operative time
    Skin-to-skin operative time
    Conversion rate
    Conversion rate
    Postoperative complication rate
    Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions
    Readmission and reoperation rate
    Readmission and reoperation rate
    Post-anesthetic discharge scoring system
    Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.
    Postoperative visual analogue scale pain score
    Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.
    Quality of Life Scoring
    Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome.
    Body image score
    Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).
    Hernia recurrence
    Hernia recurrence
    Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
    Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence

    Full Information

    First Posted
    April 2, 2022
    Last Updated
    October 8, 2022
    Sponsor
    Algemeen Ziekenhuis Maria Middelares
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05575141
    Brief Title
    Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias
    Acronym
    ROCSTAR
    Official Title
    Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: an Open-label Multicenter International Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Algemeen Ziekenhuis Maria Middelares

    4. Oversight

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

    5. Study Description

    Brief Summary
    In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventral Incisional Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    An open-label multicenter international European randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Robotic-assisted repair of wide ventral incisional hernia
    Arm Type
    Active Comparator
    Arm Description
    Robotic
    Arm Title
    Open repair of wide ventral incisional hernia
    Arm Type
    Active Comparator
    Arm Description
    Open
    Intervention Type
    Procedure
    Intervention Name(s)
    Component separation (transversus abdominis release)
    Intervention Description
    Component separation by transversus abdominis release, to allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias.
    Primary Outcome Measure Information:
    Title
    Length of postoperative hospital stay
    Description
    Length of postoperative hospital stay
    Time Frame
    From date of operation until the date of discharge, assessed up to 20 days
    Secondary Outcome Measure Information:
    Title
    Skin-to-skin operative time
    Description
    Skin-to-skin operative time
    Time Frame
    Per-operative (minutes)
    Title
    Conversion rate
    Description
    Conversion rate
    Time Frame
    Per-operative
    Title
    Postoperative complication rate
    Description
    Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions
    Time Frame
    30 days
    Title
    Readmission and reoperation rate
    Description
    Readmission and reoperation rate
    Time Frame
    30 Days
    Title
    Post-anesthetic discharge scoring system
    Description
    Minimum score is 0, maximum score is 12. The higher the score, the better the outcome.
    Time Frame
    Immediately after the surgery
    Title
    Postoperative visual analogue scale pain score
    Description
    Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome.
    Time Frame
    Immediately after the surgery
    Title
    Quality of Life Scoring
    Description
    Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome.
    Time Frame
    Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
    Title
    Body image score
    Description
    Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome).
    Time Frame
    Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months
    Title
    Hernia recurrence
    Description
    Hernia recurrence
    Time Frame
    3 Months, 12 months, 24 months, 60 months
    Title
    Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
    Description
    Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence
    Time Frame
    3 Months, 12 months, 24 months, 60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - All patients with a ventral incisional hernia of more than 8 centimeters in width Exclusion Criteria: Emergency surgery Pregnancy Age<18 Incisional hernia repair after open abdomen or enterocutaneous fistula Active wound infection Previous anterior or posterior component separation Absence of a signed informed consent Patients unable to give informed consent or complete the quality-of-life assessment (due to language barriers or intellectual capacity) Primary ventral hernias
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maaike Vierstraete, MD
    Phone
    +3292467400
    Email
    maaikevierstraete@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Filip Muysoms, MD PhD
    Organizational Affiliation
    Clinical research center Maria Middelares
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias

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