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A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.

18 Years
Open (Enrolling)
Colon Cancer, Surgery

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Trial Information

A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.

Materials and Methods:

All the patients with colon cancer will undergo elective radical operation. The observations
were recorded during the operation and on the postoperative specimens. Intra-operative
photographs were taken at various stages, as were photographs of the postoperative specimen.
According to the CME operation keypoints, all the photographs will accept third-party
assessment of the expert group, while the third-party expert group will not participate in
the management of patients. Both of The evaluators and research doctors are double-blind
state. The postoperative patients will divided into two groups according to the results of
the assessment. The clinical and pathological data of the patients as well as follow-up
information will be recorded and collected.

1. Outcome of CME By comparison to clinicopathologic variables, and precise tissues
morphometry of two groups, the prognosis, lymph nodes harvest and removal of the
mesocolic area were investigated. Outcomes of interest also include disease-free
survival, local recurrence-free survival, recurrence rate. In addition, we analyzed the
correlation between mesocolic area and height, weight, body surface area and body mass

2. Safety of CME CME group and non-CME group were compared the differences of security,
included operation time, blood loss, postoperation complications, flatus restoring
time, defecation restoring time, drainage removal time, Diet restoring time, drainage
volume in three days after surgery, hospital deaths, the exhaust time, hospitalization
time and hospitalization costs. In addition, the feasibility of CME techniques as the
surgical approach of choice for elderly patients was also evaluated.

Inclusion Criteria:

- Clinical diagnosis of colon cancer;

- Clinical stage Ⅰ ~ Ⅲ;

- Undergoing colorectal surgery for the first time;

- Accept laparotomy;

- Accept radical resection;

- More than 18 years.

Exclusion Criteria:

- Emergency surgery;

- Preoperative neoadjuvant chemoradiotherapy history;

- Combined with other malignant diseases;

- Pathological stage Ⅳ patients with colon cancer.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prognosis assessment of postoperative patients

Outcome Description:

The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.

Outcome Time Frame:

yearly, up to 5 years

Safety Issue:


Principal Investigator

Shan Wang, M.D. & Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Peking University People's Hospital


China: Beijing Municipal Science and Technology Commission

Study ID:




Start Date:

November 2012

Completion Date:

December 2018

Related Keywords:

  • Colon Cancer
  • Surgery
  • complete mesocolic excision
  • colon cancer
  • efficacy
  • safety
  • Colonic Neoplasms