Clinical trial NCT03843398: Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
Official title: Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Minilaparotomy
Survival
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 992
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 3-year overall survival, 3y OS
timeFrame: 3 years after the follow up of the last patient enrolled.
Secondary outcomes:
measure: 5-year overall survival, 5y OS
timeFrame: 5 years after the follow up of the last patient enrolled.
measure: 3-year disease free survival, 3y DFS
timeFrame: 3 years after the follow up of the last patient enrolled.
measure: 5-year disease free survival, 3y DFS
timeFrame: 5 years after the follow up of the last patient enrolled.
measure: Local recurrence rate, LRR
timeFrame: 3 years after the follow up of the last patient enrolled.
measure: Postoperative complications Incidence at 30 days
timeFrame: 30 days after the operation of the last patient enrolled.
measure: Postoperative mortality at 30 days
timeFrame: 30 days after the operation of the last patient enrolled.
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: En-Da YU, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.