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
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Minilaparotomy, Survival
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.
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
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
Learn more about this trial
Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
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