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Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multivisceral en bloc resection surgery
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T4 Colorectal cancer -

Exclusion Criteria:

  • Non primary Colorectal cancer -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Multiviceral resection colorectal cancer

    Arm Description

    Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer

    Outcomes

    Primary Outcome Measures

    Survival
    diseases free survival

    Secondary Outcome Measures

    Recurrence
    months after local or systemic recurrence for colorectal cancer

    Full Information

    First Posted
    August 1, 2016
    Last Updated
    August 5, 2016
    Sponsor
    University of Sao Paulo
    Collaborators
    CAIO SERGIO NAHAS, SERGIO CARLOS NAHAS, Ulysses Ribeiro Junior, Carlos Frederico Sparapan Marques, Rodrigo Ambar Pinto, Antonio Rocco Imperiale, Guilherme Cutait Cotti, William Carlos Nahas, Daher Cezar Chade, Dariane Sampaio Piato, Fabio Busnardo, Ivan Cecconello
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02859155
    Brief Title
    Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
    Official Title
    Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    CAIO SERGIO NAHAS, SERGIO CARLOS NAHAS, Ulysses Ribeiro Junior, Carlos Frederico Sparapan Marques, Rodrigo Ambar Pinto, Antonio Rocco Imperiale, Guilherme Cutait Cotti, William Carlos Nahas, Daher Cezar Chade, Dariane Sampaio Piato, Fabio Busnardo, Ivan Cecconello

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.
    Detailed Description
    Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. Clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. Estimated local recurrence, and overall survival were compared using the log rank method, and Cox regression analysis was used to determine the independence of the studied parameters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasms

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Multiviceral resection colorectal cancer
    Arm Type
    Other
    Arm Description
    Multiviceral resection surgery of 2 or more intrabdominal organs en bloc with colorectal cancer
    Intervention Type
    Procedure
    Intervention Name(s)
    Multivisceral en bloc resection surgery
    Intervention Description
    Multivisceral en bloc resection for colorectal cancer in advance patients (T4)
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    diseases free survival
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Recurrence
    Description
    months after local or systemic recurrence for colorectal cancer
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: T4 Colorectal cancer - Exclusion Criteria: Non primary Colorectal cancer -

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    28591336
    Citation
    Nahas CSR, Nahas SC, Ribeiro-Junior U, Bustamante-Lopez L, Marques CFS, Pinto RA, Imperiale AR, Cotti GC, Nahas WC, Chade DC, Piato DS, Busnardo F, Cecconello I. Prognostic factors affecting outcomes in multivisceral en bloc resection for colorectal cancer. Clinics (Sao Paulo). 2017 May;72(5):258-264. doi: 10.6061/clinics/2017(05)01.
    Results Reference
    derived

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    Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer

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