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

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ClinicalTrials.gov Identifier: NCT01724775
Recruitment Status : Unknown
Verified August 2016 by Shan Wang, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : November 12, 2012
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Shan Wang, Peking University People's Hospital

November 4, 2012
November 12, 2012
August 18, 2016
November 2012
November 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01724775 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer
A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Adult patients of colon caner in China
  • Colon Cancer
  • Surgery
Not Provided
  • CME surgery for colon cancer
  • non-CME surgery for colon cancer
Gao Z, Wang C, Cui Y, Shen Z, Jiang K, Shen D, Wang Y, Zhan S, Guo P, Yang X, Liu F, Shen K, Liang B, Yin M, Xie Q, Wang Y, Wang S, Ye Y. Efficacy and Safety of Complete Mesocolic Excision in Patients With Colon Cancer: Three-year Results From a Prospective, Nonrandomized, Double-blind, Controlled Trial. Ann Surg. 2018 Aug 24. doi: 10.1097/SLA.0000000000003012. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
450
300
December 2017
November 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01724775
PKPH-CME
Z121100005312015 ( Other Grant/Funding Number: Science and Technology Project of Bejing, China )
TG-2015-002 ( Other Grant/Funding Number: Capital health development research project )
20130001120064 ( Other Grant/Funding Number: Doctoral Program of Higher Education )
Yes
Not Provided
Plan to Share IPD: No
Shan Wang, Peking University People's Hospital
Shan Wang
Not Provided
Study Director: Yingjiang Ye, M.D. & Ph.D. Peking University People's Hospital
Peking University People's Hospital
August 2016