Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer

Colorectal Cancer Clinical Trial

— SoMiniCRC  

Official title:

Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03843398
• Other study ID #: SINOCOLO2019C
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2026

Study information

• Verified date: February 2019
• Source: Changhai Hospital
• Contact: Zi-Ye ZHAO, MD
• Phone: 8618699629177
• Email: yemenzhao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 992
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Laparoscopic colorectal cancer resection
This is one of the routine procedures used for colorectal cancer resection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year overall survival, 3y OS	3y OS	3 years after the follow up of the last patient enrolled.
Secondary	5-year overall survival, 5y OS	5y OS	5 years after the follow up of the last patient enrolled.
Secondary	3-year disease free survival, 3y DFS	3y DFS	3 years after the follow up of the last patient enrolled.
Secondary	5-year disease free survival, 3y DFS	5y DFS	5 years after the follow up of the last patient enrolled.
Secondary	Local recurrence rate, LRR	LRR	3 years after the follow up of the last patient enrolled.
Secondary	Postoperative complications Incidence at 30 days	PCI30	30 days after the operation of the last patient enrolled.
Secondary	Postoperative mortality at 30 days	PM30	30 days after the operation of the last patient enrolled.

External Links

•   PubMed link
•   PubMed link