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

Cai Kailin

Status and phase: Unknown; Phase 3

Conditions: Colorectal Cancer

Treatments: Procedure: laparoscopic surgery; Procedure: open surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02248038

ChiCTR-TRC-14004767 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,300 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 2 patient groups

open surgery

Active Comparator group

Description:

Conventional procedure

Treatment:

Procedure: open surgery

laparoscopic surgery

Experimental group

Description:

Minimum invasive procedure

Treatment:

Procedure: laparoscopic surgery