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Five Year Oncological Outcome After CME for Sigmoid Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03774134
Recruitment Status : Active, not recruiting
First Posted : December 12, 2018
Last Update Posted : March 13, 2019
Bispebjerg Hospital
Herlev Hospital
Hvidovre University Hospital
Zealand University Hospital
Information provided by (Responsible Party):
Nordsjaellands Hospital

Brief Summary:
Study based in existing databases investigating the causal oncological treatment effects of complete mesocolic excision on UICC stage I-III sigmoid colon cancer

Condition or disease Intervention/treatment
Sigmoid Neoplasms Procedure: Complete mesocolic excision Procedure: Conventional colon resection

Detailed Description:

Population-based cohort study, predominantly prospective based, on the same population as our previously study comparing short-term outcome after CME with conventional colon resections. The COMES database combines the prospectively registered colon cancer database in Hillerød (CME data), and data from the national database of the Danish Colorectal Cancer Group (DCCG) covering patients undergoing conventional resection (non-CME) in the other three centers. The medical records of all the patients in the non-CME group (control group) were reviewed by colorectal surgeons from Hillerød. Data audit for all CME patients was performed by various co-authors employed at the other centers. A similar audit of data for non-CME patients having postoperative complications or recurrence was performed by the co-author representing the department treating the specific patients. Follow-up data were registered prospectively in the medical records of the participating departments during patient follow-up.

Continuous data are presented as median and interquartile ranges, and categorical data as frequencies and proportions. Kruskal-Wallis test and Fisher's exact test were used as appropriate. Death is a competing risk to recurrence and time-to-event analyses were performed as competing risk analyses obtaining the cumulative incidences for recurrence or death using the "cmprsk" R-package.

Unbiased estimation of marginal or population-averaged treatment effects in observational and non-randomized studies can be obtained through different propensity score methods. Inverse Probability of Treatment Weighting (IPTW) uses the propensity score to weight each patient's data based on the inverse probability of receiving the treatment actually received. IPTW gives unbiased estimates of average treatment effects in time-to-event analyses if no differences in observed baseline covariates exist between the treatment groups. To account for baseline differences between patients in the two groups, stabilized weights truncated at the 0.99 interval were calculated using the "IPW" R-package. The following baseline covariates will be used: age, sex, ASA score, neoadjuvant chemotherapy, tumor morphology, perineural invasion, extramural venous invasion, tumor stage, and serosal invasion. All covariates used and UICC stage, two-way interactions, and squared terms of continuous covariates will be assessed for balance between the CME and the non-CME group after IPTW using the "cobalt" R-package. Absolute mean differences in mean (using standardized mean difference) and proportions (using raw mean difference) below 0.1, and variance ratios between 0.5 and 2 will be accepted. Graphical inspection of the distribution of covariates will be also performed.

The cause-specific hazards and overall survival will be analyzed using Cox regression. Binary outcomes were analyzed using logistic regression. Lymph node yield will be analyzed using linear regression after logarithmic transformation. Number of metastatic lymph nodes will be analyzed using negative binominal regression. All analyses of primary and secondary outcomes will be performed after IPTW. The 95% confidence intervals for the estimates from the original Cox regression IPTW analyses will be constructed after 1000 bootstraps with replacement, and a robust sandwich estimator will be used for the logistic regression analyses in order to ensure correct variance estimation.

All available data will be used. Model assumptions will be checked. A p-value below or equal to 0.05 will be considered significant. All analyses will be performed using R statistical software, version 3.5.1 (R Foundation for Statistical Computing, Vienna, Austria).

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Study Type : Observational
Actual Enrollment : 920 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Five Year Oncological Outcome After Complete Mesocolic Excision for Sigmoid Colon Cancer: a Population-based Cohort Study
Actual Study Start Date : June 1, 2008
Actual Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 31, 2019

Group/Cohort Intervention/treatment
CME group
The CME group consisted of patients, who underwent elective CME for sigmoid colon adenocarcinoma at Nordsjaellands Hospital Hillerød from 1 June 2008 to 31 December 2014.
Procedure: Complete mesocolic excision
Based on the principles of CME. The inferior mesenteric artery (IMA) was divided at its origin from the aorta to perform central lymph nodes dissection along the IMA between the aorta and the branching of the left colic artery. Sigmoid resection included the complete sigmoid colon and resection of the upper part of the rectum to ensure sufficient perfusion of the colo-rectal anastomosis. To achieve sufficient distance at the proximal bowel resection margin, parts of the descending colon or even left hemicolectomy were performed at the surgeon's discretion.

Non-CME group
The non-CME group comprised patients having a elective conventional colon cancer resection for sigmoid adenocarcinoma at the other three colorectal centers in the Capital Region of Denmark from 1 June 2008 to 31 December 2013.
Procedure: Conventional colon resection
The patients underwent what was considered standard colon cancer resections in Denmark during the study period.

Primary Outcome Measures :
  1. Risk of recurrence [ Time Frame: 5.2 years ]

    Recurrence diagnosed by CT or positron emission tomography (PET)/CT of thorax and abdomen, chest radiograph and contrast-enhanced ultrasound of the liver, or laparotomy in case of suspicion of recurrence. Histological

    - Page 4 of 6 - verification of radiological findings of metastases during follow-up is not needed if the local multidisciplinary team conference deemed the finding as a recurrence. Metachronous colon tumors diagnosed during follow-up are considered as recurrences only if located in the anastomosis and with the same morphology as the primary tumor.

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5.2 years ]
    Death by any cause

  2. Short-term mortality [ Time Frame: 30 and 90 days ]
    Death from any cause within 30 and 90 days

  3. Rate of postoperative complications [ Time Frame: 60 days ]
    Patients having surgical and non-surgical postoperative complications and with complications with Clavien-Dindo score of 3b or more

  4. Mesocolic lymph nodes yield [ Time Frame: 1 day ]
    Median number of lymph nodes detected in the specimens and proportion of specimens with 22 or more lymph nodes detected

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Data for all patients undergoing elective surgery for UICC stage I-III colonic adenocarcinoma in the Capital Region of Denmark. The population of this region is approximately 1⋅75 million, more than 30 per cent of the population of Denmark, and it is served by only four public university colorectal cancer centres.

Inclusion Criteria:

  • Sigmoid colon cancer was defined as primary adenocarcinomas located in the sigmoid colon (more than 15 cm from the anal verge)
  • UICC stage I-III

Exclusion Criteria:

  • Synchronous colorectal cancer - even in the sigmoid colon
  • No residual tumor in the specimen after neoadjuvant chemotherapy
  • Metachronous colorectal cancer
  • Resections in Hillerød not performed according to the principles of CME
  • Non-macroradical (R2) resections (peroperative assessment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03774134

Sponsors and Collaborators
Nordsjaellands Hospital
Bispebjerg Hospital
Herlev Hospital
Hvidovre University Hospital
Zealand University Hospital
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Study Chair: Claus A Bertelsen, PhD, MD Department of Surgery, Nordsjaellands Hospital Hillerød

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Responsible Party: Nordsjaellands Hospital Identifier: NCT03774134    
Other Study ID Numbers: CMELoS2019
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordsjaellands Hospital:
Colon cancer
Oncological outcome
Additional relevant MeSH terms:
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Colonic Neoplasms
Sigmoid Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Sigmoid Diseases