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

Phase 3

• Conditions: Colorectal Cancer
• Interventions: Procedure: open surgery; Procedure: laparoscopic surgery

• Registration Number: NCT02248038
• Lead Sponsor: Cai Kailin

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

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-23
• Last Update Submitted: 2014-09-23
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open surgery	open surgery	Conventional procedure
laparoscopic surgery	laparoscopic surgery	Minimum invasive procedure

Primary Outcome Measures

Name	Time	Method
5 years diseases free survival rate	five years
5 years overall survival rate	five years

Trial Locations

Locations (1)

Union Hospital, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China