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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Laparoscopic colorectal cancer resection; Procedure: Colorectal cancer resection via minilaparotomy

• Study Type: Interventional
• Enrollment (Anticipated): 992
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zi-Ye ZHAO, MD; Phone Number: 8618699629177; Email: yemenzhao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minilaparotomy Group; Participants in this arm undergo colorectal cancer resection via minilaparotomy.	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 Names: Minilaparotomy
Active Comparator: Laparoscopy Group; Participants in this arm undergo laparoscopic colorectal cancer resection.	Procedure: Laparoscopic colorectal cancer resection; This is one of the routine procedures used for colorectal cancer resection.; Other Names: Laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival, 3y OS	3y OS	3 years after the follow up of the last patient enrolled.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: En-Da YU, MBBS, Changhai Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• PubMed link
• PubMed link

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Survival; Colorectal Cancer; Minilaparotomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SINOCOLO2019C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No