Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer

Summary

Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer.

Conditions

• Colon Cancer

Interventions

PROCEDURE

Open surgery

A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.

PROCEDURE

Laparoscopic surgery

3-5 small incisions are made through the abdominal wall for the placement of trocars and the abdominal cavity is insufflated with carbon dioxide to allow access, visualization and operation. A 6-8cm auxiliary incision is made for specimen extraction and anastomosis. Conversion may occur due to technical difficulties or intraoperative complications, which is defined when completion of the dissection of the mesocolon is performed through a traditional open abdominal approach. Patients undergo conversion to laparotomy will be excluded from this study.

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Fujian Medical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Fumin Zhang, Professor · Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2023-04-30

Completion

2023-04-30

Countries

• China

Study Locations