Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer (ESCME)

Shan Wang

Status: Unknown

Conditions: Surgery; Colon Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01724775

PKPH-CME

Z121100005312015 (Other Grant/Funding Number)

20130001120064 (Other Grant/Funding Number)

TG-2015-002 (Other Grant/Funding Number)

Details and patient eligibility

About

In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in which the same principle of TME in rectal cancer has been applied to the colon. More and more surgeons pay attention to the rationality of this surgical approach. However, the clinical application researches are still few, in particular the prospective controlled study is still none. This clinical trial will compare the CME group and non-CME group to evaluate the outcome and safety of CME for apply in clinic.

Full description

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 index.
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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

450 participants in 2 patient groups

CME surgery for colon cancer

non-CME surgery for colon cancer