Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer (ESCME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01724775|
Recruitment Status : Recruiting
First Posted : November 12, 2012
Last Update Posted : August 18, 2016
|Condition or disease|
|Colon Cancer Surgery|
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.
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
|CME surgery for colon cancer|
|non-CME surgery for colon cancer|
- Prognosis assessment of postoperative patients [ Time Frame: yearly, up to 5 years ]The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.
- Safety assessment of the patients in perioperation period [ Time Frame: Daily, up to one month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724775
|Contact: Zhidong Gao, M.D.||firstname.lastname@example.org|
|Department of Gastroenterology Surgery, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Zhidong Gao, M.D. 8610-88326600 email@example.com|
|Principal Investigator: Yingjiang Ye, M.D. & Ph.D.|
|Study Director:||Yingjiang Ye, M.D. & Ph.D.||Peking University People's Hospital|