Surgery Clinical Trial
Official title:
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.
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Observational Model: Cohort, Time Perspective: Prospective
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