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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Peking University People's Hospital
Sponsor:
Information provided by (Responsible Party):
Shan Wang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01724775
First received: November 4, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition
Colon Cancer
Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • Prognosis assessment of postoperative patients [ Time Frame: yearly, up to 5 years ] [ Designated as safety issue: No ]
    The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.


Secondary Outcome Measures:
  • Safety assessment of the patients in perioperation period [ Time Frame: Daily, up to one month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
CME surgery for colon cancer
non-CME surgery for colon cancer

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients of colon caner in China

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724775

Contacts
Contact: Shan Wang, M.D. & Ph.D. 15810195892 xiaoya-008@163.com

Locations
China, Beijing
Department of Gastroenterology Surgery, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Zhidong Gao, M.D.    8610-88326600    xiaoya-008@163.com   
Sponsors and Collaborators
Shan Wang
Investigators
Study Director: Shan Wang, M.D. & Ph.D. Peking University People's Hospital
  More Information

No publications provided

Responsible Party: Shan Wang, Gastroenterology Surgery Department, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01724775     History of Changes
Other Study ID Numbers: PKPH-CME, 2012-08-01
Study First Received: November 4, 2012
Last Updated: November 21, 2012
Health Authority: China: Beijing Municipal Science and Technology Commission
China: Ethics Committee

Keywords provided by Peking University People's Hospital:
complete mesocolic excision
colon cancer
efficacy
safety

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014