Clinical trial NCT01724775: Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer
Official title: A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Surgery
Keywords: complete mesocolic excision
colon cancer
efficacy
safety
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients of colon caner in China

Brief summary: 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.

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 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.

Primary outcomes:
measure: Prognosis assessment of postoperative patients
timeFrame: yearly, up to 5 years
Secondary outcomes:
measure: Safety assessment of the patients in perioperation period
timeFrame: Daily, up to one month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Gastroenterology Surgery, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yingjiang Ye, M.D. & Ph.D.
role: STUDY_DIRECTOR
References:
citation: Wang C, Gao Z, Shen Z, Jiang K, Zhou J, Wang S, Ye Y. Five-Year Prognosis of Complete Mesocolic Excision in Patients with Colon Cancer: A Prospective, Nonrandomized, Double-Blind Controlled Trial. J Am Coll Surg. 2022 Oct 1;235(4):666-676. doi: 10.1097/XCS.0000000000000282. Epub 2022 Sep 15.
citation: 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. 2020 Mar;271(3):519-526. doi: 10.1097/SLA.0000000000003012.