A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery

Cai Kailin1,300 enrolled

Overview

The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery. Study design：Randomized parallel control

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,300

Conditions

Colorectal Cancer

Interventions

open surgeryPROCEDURE

Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.

laparoscopic surgeryPROCEDURE

Patients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients.

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. informed consent 2. single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line 3. cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm 4. age less than 80 years old 5. normal blood routine test and hepatic or renal function test 6. no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction. Exclusion Criteria: 1. severe comorbidity such as heart attack or stroke, malignance in 5 years 2. can not tolerate to general anesthesia, pneumoperitoneum or surgery 3. pregnant or during breast-feeding period 4. attending other clinical trial involving therapy 5. cannot or disagree to attending the clinical trial

Locations (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

5 years diseases free survival rate

Time frame: five years

5 years overall survival rate

Time frame: five years

Data from ClinicalTrials.gov

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