Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843398
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
En-Da Yu, Changhai Hospital

Tracking Information
First Submitted Date  ICMJE February 13, 2019
First Posted Date  ICMJE February 18, 2019
Last Update Posted Date February 18, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
3-year overall survival, 3y OS [ Time Frame: 3 years after the follow up of the last patient enrolled. ]
3y OS
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • 5-year overall survival, 5y OS [ Time Frame: 5 years after the follow up of the last patient enrolled. ]
    5y OS
  • 3-year disease free survival, 3y DFS [ Time Frame: 3 years after the follow up of the last patient enrolled. ]
    3y DFS
  • 5-year disease free survival, 3y DFS [ Time Frame: 5 years after the follow up of the last patient enrolled. ]
    5y DFS
  • Local recurrence rate, LRR [ Time Frame: 3 years after the follow up of the last patient enrolled. ]
    LRR
  • Postoperative complications Incidence at 30 days [ Time Frame: 30 days after the operation of the last patient enrolled. ]
    PCI30
  • Postoperative mortality at 30 days [ Time Frame: 30 days after the operation of the last patient enrolled. ]
    PM30
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
Official Title  ICMJE Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Procedure: Colorectal cancer resection via minilaparotomy
    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.
    Other Name: Minilaparotomy
  • Procedure: Laparoscopic colorectal cancer resection
    This is one of the routine procedures used for colorectal cancer resection.
    Other Name: Laparoscopy
Study Arms  ICMJE
  • Experimental: Minilaparotomy Group
    Participants in this arm undergo colorectal cancer resection via minilaparotomy.
    Intervention: Procedure: Colorectal cancer resection via minilaparotomy
  • Active Comparator: Laparoscopy Group
    Participants in this arm undergo laparoscopic colorectal cancer resection.
    Intervention: Procedure: Laparoscopic colorectal cancer resection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2019)
992
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2026
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zi-Ye ZHAO, MD 8618699629177 yemenzhao@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03843398
Other Study ID Numbers  ICMJE SINOCOLO2019C
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party En-Da Yu, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: En-Da YU, MBBS Changhai Hospital
PRS Account Changhai Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP