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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02248038

Enrollment

1300

Registered

2014-09-25

Start date

2014-06-30

Completion date

2019-06-30

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

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.

Detailed description

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

Interventions

PROCEDUREopen surgery

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

PROCEDURElaparoscopic surgery

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
5 years diseases free survival rate	five years
5 years overall survival rate	five years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026