Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer (ESCME)
Verified August 2016 by Peking University People's Hospital
Information provided by (Responsible Party):
Shan Wang, Peking University People's Hospital
First received: November 4, 2012
Last updated: August 17, 2016
Last verified: August 2016
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2017 (Final data collection date for primary outcome measure)
CME surgery for colon cancer
non-CME surgery 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.
- 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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult patients of colon caner in China
- 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.
- Emergency surgery;
- Preoperative neoadjuvant chemoradiotherapy history;
- Combined with other malignant diseases;
- Pathological stage Ⅳ patients with colon cancer.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01724775
|Department of Gastroenterology Surgery, Peking University People's Hospital
|Beijing, Beijing, China, 100044 |
|Contact: Zhidong Gao, M.D. 8610-88326600 email@example.com |
|Principal Investigator: Yingjiang Ye, M.D. & Ph.D. |
||Yingjiang Ye, M.D. & Ph.D.
||Peking University People's Hospital
||Shan Wang, Department of Gastrointestinal Surgery, Peking University People's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 4, 2012
||August 17, 2016
||China: Beijing Municipal Science and Technology Commission
China: Ethics Committee
|Individual Participant Data
|Plan to Share IPD:
Keywords provided by Peking University People's Hospital:
complete mesocolic excision
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2016
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases