Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
SoMiniCRC
1 other identifier
interventional
992
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Apr 2019
Longer than P75 for not_applicable colorectal-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFebruary 18, 2019
February 1, 2019
5 years
February 13, 2019
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-year overall survival, 3y OS
3y OS
3 years after the follow up of the last patient enrolled.
Secondary Outcomes (6)
5-year overall survival, 5y OS
5 years after the follow up of the last patient enrolled.
3-year disease free survival, 3y DFS
3 years after the follow up of the last patient enrolled.
5-year disease free survival, 3y DFS
5 years after the follow up of the last patient enrolled.
Local recurrence rate, LRR
3 years after the follow up of the last patient enrolled.
Postoperative complications Incidence at 30 days
30 days after the operation of the last patient enrolled.
- +1 more secondary outcomes
Study Arms (2)
Minilaparotomy Group
EXPERIMENTALParticipants in this arm undergo colorectal cancer resection via minilaparotomy.
Laparoscopy Group
ACTIVE COMPARATORParticipants in this arm undergo laparoscopic colorectal cancer resection.
Interventions
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.
This is one of the routine procedures used for colorectal cancer resection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 23066325BACKGROUNDIshida 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.
PMID: 22026303BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
En-Da YU, MBBS
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy
Study Record Dates
First Submitted
February 13, 2019
First Posted
February 18, 2019
Study Start
April 1, 2019
Primary Completion
April 1, 2024
Study Completion
April 1, 2026
Last Updated
February 18, 2019
Record last verified: 2019-02