Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer

NCT01724775 | Unknown DMC

• 4 other identifiers: PKPH-CMEZ121100005312015TG-2015-00220130001120064
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Surgery

Keywords

complete mesocolic excision; colon cancer; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Prognosis assessment of postoperative patients

  The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.

  yearly, up to 5 years

Secondary Outcomes (1)

• Safety assessment of the patients in perioperation period

  Daily, up to one month

Study Arms (2)

CME surgery for colon cancer

non-CME surgery for colon cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients of colon caner in China

You may qualify if:

• 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.

You may not qualify if:

• Emergency surgery;
• Preoperative neoadjuvant chemoradiotherapy history;
• Combined with other malignant diseases;
• Pathological stage Ⅳ patients with colon cancer.

Sponsors & Collaborators

• Shan Wang: lead

Study Sites (1)

Department of Gastroenterology Surgery, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 36106868 DERIVED

• 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.

  PMID: 30148752 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Yingjiang Ye, M.D. & Ph.D.

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhidong Gao, M.D.

CONTACT

15810195892; xiaoya-008@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Gastrointestinal Surgery

Study Record Dates

• First Submitted: November 4, 2012
• First Posted: November 12, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)