Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer

Surgery Clinical Trial

— ESCME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01724775
• Other study ID #: PKPH-CME
• Secondary ID: Z121100005312015
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2012
• Last updated: August 17, 2016
• Start date: November 2012
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Peking University People's Hospital
• Contact: Zhidong Gao, M.D.
• Phone: 15810195892
• Email: xiaoya-008[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology CommissionChina: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of colon cancer;

• Clinical stage ? ~ ?;

• 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 ? patients with colon cancer.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Surgery

Locations

Country	Name	City	State
China	Department of Gastroenterology Surgery, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shan Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis assessment of postoperative patients	The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.	yearly, up to 5 years	No
Secondary	Safety assessment of the patients in perioperation period	Includes: postoperative complications, hospital mortality, operative time, blood loss, exhaust time, defecation time, drainage and unplug time, resumed eating time, drainage volume during postoperation three days and so on.	Daily, up to one month	No