Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer
NCT ID: NCT01724775
Last Updated: 2016-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
450 participants
OBSERVATIONAL
2012-11-30
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CME surgery for colon cancer
No interventions assigned to this group
non-CME surgery for colon cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinical stage Ⅰ \~ Ⅲ;
* Undergoing colorectal surgery for the first time;
* Accept laparotomy;
* Accept radical resection;
* More than 18 years.
Exclusion Criteria
* Preoperative neoadjuvant chemoradiotherapy history;
* Combined with other malignant diseases;
* Pathological stage Ⅳ patients with colon cancer.
18 Years
ALL
No
Sponsors
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Shan Wang
OTHER
Responsible Party
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Shan Wang
Department of Gastrointestinal Surgery
Principal Investigators
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Yingjiang Ye, M.D. & Ph.D.
Role: STUDY_DIRECTOR
Peking University People's Hospital
Locations
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Department of Gastroenterology Surgery, Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Z121100005312015
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TG-2015-002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20130001120064
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PKPH-CME
Identifier Type: -
Identifier Source: org_study_id
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