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Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient (LAROPA)

Primary Purpose

Parastomal Hernia, Oncology

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia
Laparoscopic Surgery for the Treatment of Parastomal Hernia
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parastomal Hernia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with PH in permanent ostomy, aged between 18 and 75 years, undergoing surgery for cancer treatment at ICESP, with stable cancer disease (recurrence or metastasis without evolution) or in follow-up after treatment with curative intent, who have computed tomography with a diagnosis of HP, and who agree to participate in the study.

Exclusion Criteria:

  • Patient with progressive cancer disease. Presence of disease that prevents the performance of videolaparoscopic surgical procedure such as severe heart failure, severe lung disease, etc. Clinical criteria according to the research team that may indicate the application of another specific technique that is not covered in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Robot Assisted Laparoscopic

    Conventional Laparoscopic Surgery

    Arm Description

    Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

    Conventional Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient

    Outcomes

    Primary Outcome Measures

    To study the return time of ostomy functioning of patients approached by laparoscopic assisted robot using the Sugarbaker technique using a semi-absorbable biosynthetic mesh.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 25, 2021
    Last Updated
    June 25, 2021
    Sponsor
    Instituto do Cancer do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04950140
    Brief Title
    Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
    Acronym
    LAROPA
    Official Title
    Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 24, 2021 (Anticipated)
    Primary Completion Date
    September 24, 2021 (Anticipated)
    Study Completion Date
    July 24, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto do Cancer do Estado de São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Prospective randomized prospective interventional study with 40 consecutive patients for whom surgical treatment for PH was indicated and who are in postoperative follow-up with the Oncology Surgery group of the Department of Digestive Tract Surgery and Coloproctology, Faculty of Medicine, University of São Paulo . The free and informed consent form will be applied to the patient by the researchers in two copies of equal content and after any doubts related to the research are resolved, the patient will sign the copies together with the researcher. At any time, the patient may opt out of the study. The contacts of the researchers and the institution will be fully available to the research subject to resolve doubts and for any eventuality that may occur.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parastomal Hernia, Oncology

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Robot Assisted Laparoscopic
    Arm Type
    Experimental
    Arm Description
    Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
    Arm Title
    Conventional Laparoscopic Surgery
    Arm Type
    Active Comparator
    Arm Description
    Conventional Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
    Intervention Type
    Procedure
    Intervention Name(s)
    Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia
    Intervention Description
    Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Surgery for the Treatment of Parastomal Hernia
    Intervention Description
    Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients
    Primary Outcome Measure Information:
    Title
    To study the return time of ostomy functioning of patients approached by laparoscopic assisted robot using the Sugarbaker technique using a semi-absorbable biosynthetic mesh.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with PH in permanent ostomy, aged between 18 and 75 years, undergoing surgery for cancer treatment at ICESP, with stable cancer disease (recurrence or metastasis without evolution) or in follow-up after treatment with curative intent, who have computed tomography with a diagnosis of HP, and who agree to participate in the study. Exclusion Criteria: Patient with progressive cancer disease. Presence of disease that prevents the performance of videolaparoscopic surgical procedure such as severe heart failure, severe lung disease, etc. Clinical criteria according to the research team that may indicate the application of another specific technique that is not covered in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ricardo Abdalla
    Phone
    +551121892646
    Email
    ricardo.abdalla@hc.fm.usp.br

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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