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Open Versus Robotic Retromuscular Ventral Hernia Repair (ORREO)

Primary Purpose

Ventral Hernia

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
open ventral hernia repair
robotic ventral hernia repair
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring Hernia repair, Robotic hernia repair, Open hernia repair, Incisional hernia

Eligibility Criteria

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

Inclusion Criteria:

  • Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm.
  • At least one of the following risk factors: Body Mass Index > 30, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month)

Exclusion Criteria:

  • Current abdominal wall infection
  • Presence of ileostomy, colostomy, or ileal conduit
  • Center for Disease Control wound class 3 or 4
  • Hernia defect < 7 cm or >15 cm
  • Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    robotic ventral hernia repair (VHR)

    open ventral hernia repair (VHR)

    Arm Description

    Robotic VHR

    Open VHR

    Outcomes

    Primary Outcome Measures

    Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence
    A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.

    Secondary Outcome Measures

    All surgical site occurrences
    Surgical site occurrences requiring procedural intervention
    All surgical site infections
    Surgical site infections requiring procedural intervention
    Length of stay at hospital measured in days
    Operative time (procedure start to procedure finish measured in minutes)
    Quality of Life via questionnaire
    Cost for hospital charges from billing office

    Full Information

    First Posted
    December 15, 2016
    Last Updated
    January 17, 2023
    Sponsor
    Prisma Health-Upstate
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03007758
    Brief Title
    Open Versus Robotic Retromuscular Ventral Hernia Repair
    Acronym
    ORREO
    Official Title
    Prospective Randomized Control Trial of Open Versus Robotic REtrOmuscular Ventral Hernia Repair (ORREO Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Prisma Health-Upstate

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine how the robotic retromuscular hernia repair compares to the open retromuscular hernia repair for large hernia defects in patients at higher risk of wound complications.
    Detailed Description
    All patients presenting to the Greenville Health System Hernia Center who meet the inclusion criteria will be considered for enrollment. Patients who qualify and agree to participate will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular ventral hernia repair. Data to be collected includes the following: demographic information, medical characteristics, medications, medical and surgical history, operative details, hospital stay data, and patient-reported outcomes via a quality of life questionnaire. Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventral Hernia
    Keywords
    Hernia repair, Robotic hernia repair, Open hernia repair, Incisional hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    robotic ventral hernia repair (VHR)
    Arm Type
    Active Comparator
    Arm Description
    Robotic VHR
    Arm Title
    open ventral hernia repair (VHR)
    Arm Type
    Active Comparator
    Arm Description
    Open VHR
    Intervention Type
    Procedure
    Intervention Name(s)
    open ventral hernia repair
    Intervention Description
    An open retromuscular ventral hernia repair involves an incision through your abdominal wall, most often through a prior surgery scar. The contents of the hernia, which may include intestine or fatty tissue, are returned into the abdominal cavity. The posterior (inner-most) layer of the abdominal wall is separated from the muscle and closed, which closes the abdominal cavity. Mesh is then placed over that closed layer, which is outside of the abdominal cavity, but below the abdominal muscles. The anterior (outer-most) layer of the abdominal wall is then closed over the mesh, which closes the hernia.
    Intervention Type
    Procedure
    Intervention Name(s)
    robotic ventral hernia repair
    Intervention Description
    A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar mesh placement, and similar closure of the hernia defect. The surgical robot is a tool that allows your surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of your abdomen. Rather than one longer incision in the middle of your abdomen, four to six small incisions, about 1 inch, are made along the outer part of your abdomen between the rib cage and hip.
    Primary Outcome Measure Information:
    Title
    Composite outcome of diagnosis of surgical site occurrence or infection, hospital readmission, or hernia recurrence
    Description
    A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.
    Time Frame
    Through study completion, an average of 2 years
    Secondary Outcome Measure Information:
    Title
    All surgical site occurrences
    Time Frame
    Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
    Title
    Surgical site occurrences requiring procedural intervention
    Time Frame
    Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
    Title
    All surgical site infections
    Time Frame
    Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
    Title
    Surgical site infections requiring procedural intervention
    Time Frame
    Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
    Title
    Length of stay at hospital measured in days
    Time Frame
    Time from procedure until discharge, an expected range of 2 to10 days
    Title
    Operative time (procedure start to procedure finish measured in minutes)
    Time Frame
    Day of surgery
    Title
    Quality of Life via questionnaire
    Time Frame
    Baseline and Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years
    Title
    Cost for hospital charges from billing office
    Time Frame
    Through study completion, an average of 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm. At least one of the following risk factors: Body Mass Index > 30, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month) Exclusion Criteria: Current abdominal wall infection Presence of ileostomy, colostomy, or ileal conduit Center for Disease Control wound class 3 or 4 Hernia defect < 7 cm or >15 cm Pregnant women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeremy A Warren, MD
    Organizational Affiliation
    Prisma Health-Upstate
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.

    Learn more about this trial

    Open Versus Robotic Retromuscular Ventral Hernia Repair

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