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Status unknownNCT01724775ESCMEUpdated Aug 18, 2016

Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer

An observational study in Colon Cancer and Surgery, sponsored by Shan Wang. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-18.

Sponsored by Shan Wang · Observational

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.
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Conditions studied

  • Colon Cancer
  • Surgery

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Keywords

  • complete mesocolic excision
  • colon cancer
  • efficacy
  • safety
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In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 450 is above the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Shan Wang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients of colon caner in China

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)

Groups and cohorts

  • CME surgery for colon cancer
  • non-CME surgery for colon cancer
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What researchers measure

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.

    Time frame: yearly, up to 5 years

Secondary outcomes

  1. Safety assessment of the patients in perioperation period

    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.

    Time frame: Daily, up to one month

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Study locations

1 of 1 sites recruiting
  • Department of Gastroenterology Surgery, Peking University People's Hospital
    Beijing, Beijing 100044, China
    • Zhidong Gao, M.D. · Contact · xiaoya-008@163.com · 8610-88326600
    • Yingjiang Ye, M.D. & Ph.D. · Principal investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 36106868 ↗
  • 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. PubMed 30148752 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01724775
Lead sponsor
Shan Wang
Responsible party
Shan Wang (Department of Gastrointestinal Surgery, Peking University People's Hospital) — Sponsor-investigator
First posted
Nov 12, 2012
Start date
Nov 2012
Primary completion
Nov 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Aug 18, 2016

Study contacts

Zhidong Gao, M.D.
Contact
xiaoya-008@163.com
15810195892
Yingjiang Ye, M.D. & Ph.D.
study director · Peking University People's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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