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Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer (SoMiniCRC)

Primary Purpose

Colorectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Colorectal cancer resection via minilaparotomy
Laparoscopic colorectal cancer resection
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Minilaparotomy, Survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Colorectal cancer with pathological results.
  • Colorectal cancer preliminary diagnosed during colonoscopy.
  • No confirmed metastasis.
  • No comorbidity of other malignancy.
  • The primary tumor is less than 10 cm.
  • No organ dysfunction.
  • The patient and his families totally agree with the whole investigative procedure, and sign the written informed consent form.

Exclusion Criteria:

  • Diagnosed with any other malignancy within 5 years.
  • Comorbidity of emergent conditions like perforation.
  • Former colorectal surgery history which may affects digestive tract reconstruction.
  • Need combined organ resection.
  • ASA grade IV or V.
  • Pregnant or lactating Women.
  • Severe mental diseases.
  • Severe cardiopulmonary diseases which reduce operation tolerance.
  • Systematic steroid therapy lasting for more than 1 month.
  • Intolerant of laparoscopy.
  • No written informed consent form signed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Minilaparotomy Group

    Laparoscopy Group

    Arm Description

    Participants in this arm undergo colorectal cancer resection via minilaparotomy.

    Participants in this arm undergo laparoscopic colorectal cancer resection.

    Outcomes

    Primary Outcome Measures

    3-year overall survival, 3y OS
    3y OS

    Secondary Outcome Measures

    5-year overall survival, 5y OS
    5y OS
    3-year disease free survival, 3y DFS
    3y DFS
    5-year disease free survival, 3y DFS
    5y DFS
    Local recurrence rate, LRR
    LRR
    Postoperative complications Incidence at 30 days
    PCI30
    Postoperative mortality at 30 days
    PM30

    Full Information

    First Posted
    February 13, 2019
    Last Updated
    February 14, 2019
    Sponsor
    Changhai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03843398
    Brief Title
    Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
    Acronym
    SoMiniCRC
    Official Title
    Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Changhai Hospital

    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 primary aim of this study is - to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy.. Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other. 3-year disease free survival, 3y DFS 5-year overall survival, 5y OS 5-year disease free survival, 5y DFS Local recurrence rate, LRR Postoperative complications Incidence and mortality at 30 days

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    Colorectal Cancer, Minilaparotomy, Survival

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Minilaparotomy Group
    Arm Type
    Experimental
    Arm Description
    Participants in this arm undergo colorectal cancer resection via minilaparotomy.
    Arm Title
    Laparoscopy Group
    Arm Type
    Active Comparator
    Arm Description
    Participants in this arm undergo laparoscopic colorectal cancer resection.
    Intervention Type
    Procedure
    Intervention Name(s)
    Colorectal cancer resection via minilaparotomy
    Other Intervention Name(s)
    Minilaparotomy
    Intervention Description
    According to the cancer location, a 7 cm incision is made in specific area of the patient's abdomen. The whole procedure of operation will be finished within this incision. If the incision must be lengthen due to the surgical demand, the failure of the minilaparotomy is determined.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic colorectal cancer resection
    Other Intervention Name(s)
    Laparoscopy
    Intervention Description
    This is one of the routine procedures used for colorectal cancer resection.
    Primary Outcome Measure Information:
    Title
    3-year overall survival, 3y OS
    Description
    3y OS
    Time Frame
    3 years after the follow up of the last patient enrolled.
    Secondary Outcome Measure Information:
    Title
    5-year overall survival, 5y OS
    Description
    5y OS
    Time Frame
    5 years after the follow up of the last patient enrolled.
    Title
    3-year disease free survival, 3y DFS
    Description
    3y DFS
    Time Frame
    3 years after the follow up of the last patient enrolled.
    Title
    5-year disease free survival, 3y DFS
    Description
    5y DFS
    Time Frame
    5 years after the follow up of the last patient enrolled.
    Title
    Local recurrence rate, LRR
    Description
    LRR
    Time Frame
    3 years after the follow up of the last patient enrolled.
    Title
    Postoperative complications Incidence at 30 days
    Description
    PCI30
    Time Frame
    30 days after the operation of the last patient enrolled.
    Title
    Postoperative mortality at 30 days
    Description
    PM30
    Time Frame
    30 days after the operation of the last patient enrolled.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Colorectal cancer with pathological results. Colorectal cancer preliminary diagnosed during colonoscopy. No confirmed metastasis. No comorbidity of other malignancy. The primary tumor is less than 10 cm. No organ dysfunction. The patient and his families totally agree with the whole investigative procedure, and sign the written informed consent form. Exclusion Criteria: Diagnosed with any other malignancy within 5 years. Comorbidity of emergent conditions like perforation. Former colorectal surgery history which may affects digestive tract reconstruction. Need combined organ resection. ASA grade IV or V. Pregnant or lactating Women. Severe mental diseases. Severe cardiopulmonary diseases which reduce operation tolerance. Systematic steroid therapy lasting for more than 1 month. Intolerant of laparoscopy. No written informed consent form signed.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zi-Ye ZHAO, MD
    Phone
    8618699629177
    Email
    yemenzhao@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    En-Da YU, MBBS
    Organizational Affiliation
    Changhai Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23066325
    Citation
    Wang XD, Huang MJ, Yang CH, Li K, Li L. Minilaparotomy to rectal cancer has higher overall survival rate and earlier short-term recovery. World J Gastroenterol. 2012 Oct 7;18(37):5289-94. doi: 10.3748/wjg.v18.i37.5289.
    Results Reference
    background
    PubMed Identifier
    22026303
    Citation
    Ishida H, Ishiguro T, Ohsawa T, Okada N, Kumamoto K, Ishibashi K, Haga N, Yokoyama M, Nakada H, Gonda T. Oncologic outcome of stages II/III colon cancer treated via minilaparotomy. Int Surg. 2011 Apr-Jun;96(2):127-34. doi: 10.9738/1384.1.
    Results Reference
    background
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/23066325
    Description
    PubMed link
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/22026303
    Description
    PubMed link

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    Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer

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