<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03774134</url>
  </required_header>
  <id_info>
    <org_study_id>CMELoS2019</org_study_id>
    <nct_id>NCT03774134</nct_id>
  </id_info>
  <brief_title>Five Year Oncological Outcome After CME for Sigmoid Colon Cancer</brief_title>
  <official_title>Five Year Oncological Outcome After Complete Mesocolic Excision for Sigmoid Colon Cancer: a Population-based Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nordsjaellands Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nordsjaellands Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study based in existing databases investigating the causal oncological treatment effects of&#xD;
      complete mesocolic excision on UICC stage I-III sigmoid colon cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Population-based cohort study, predominantly prospective based, on the same population as our&#xD;
      previously study comparing short-term outcome after CME with conventional colon resections.&#xD;
      The COMES database combines the prospectively registered colon cancer database in Hillerød&#xD;
      (CME data), and data from the national database of the Danish Colorectal Cancer Group (DCCG)&#xD;
      covering patients undergoing conventional resection (non-CME) in the other three centers. The&#xD;
      medical records of all the patients in the non-CME group (control group) were reviewed by&#xD;
      colorectal surgeons from Hillerød. Data audit for all CME patients was performed by various&#xD;
      co-authors employed at the other centers. A similar audit of data for non-CME patients having&#xD;
      postoperative complications or recurrence was performed by the co-author representing the&#xD;
      department treating the specific patients. Follow-up data were registered prospectively in&#xD;
      the medical records of the participating departments during patient follow-up.&#xD;
&#xD;
      Continuous data are presented as median and interquartile ranges, and categorical data as&#xD;
      frequencies and proportions. Kruskal-Wallis test and Fisher's exact test were used as&#xD;
      appropriate. Death is a competing risk to recurrence and time-to-event analyses were&#xD;
      performed as competing risk analyses obtaining the cumulative incidences for recurrence or&#xD;
      death using the &quot;cmprsk&quot; R-package.&#xD;
&#xD;
      Unbiased estimation of marginal or population-averaged treatment effects in observational and&#xD;
      non-randomized studies can be obtained through different propensity score methods. Inverse&#xD;
      Probability of Treatment Weighting (IPTW) uses the propensity score to weight each patient's&#xD;
      data based on the inverse probability of receiving the treatment actually received. IPTW&#xD;
      gives unbiased estimates of average treatment effects in time-to-event analyses if no&#xD;
      differences in observed baseline covariates exist between the treatment groups. To account&#xD;
      for baseline differences between patients in the two groups, stabilized weights truncated at&#xD;
      the 0.99 interval were calculated using the &quot;IPW&quot; R-package. The following baseline&#xD;
      covariates will be used: age, sex, ASA score, neoadjuvant chemotherapy, tumor morphology,&#xD;
      perineural invasion, extramural venous invasion, tumor stage, and serosal invasion. All&#xD;
      covariates used and UICC stage, two-way interactions, and squared terms of continuous&#xD;
      covariates will be assessed for balance between the CME and the non-CME group after IPTW&#xD;
      using the &quot;cobalt&quot; R-package. Absolute mean differences in mean (using standardized mean&#xD;
      difference) and proportions (using raw mean difference) below 0.1, and variance ratios&#xD;
      between 0.5 and 2 will be accepted. Graphical inspection of the distribution of covariates&#xD;
      will be also performed.&#xD;
&#xD;
      The cause-specific hazards and overall survival will be analyzed using Cox regression. Binary&#xD;
      outcomes were analyzed using logistic regression. Lymph node yield will be analyzed using&#xD;
      linear regression after logarithmic transformation. Number of metastatic lymph nodes will be&#xD;
      analyzed using negative binominal regression. All analyses of primary and secondary outcomes&#xD;
      will be performed after IPTW. The 95% confidence intervals for the estimates from the&#xD;
      original Cox regression IPTW analyses will be constructed after 1000 bootstraps with&#xD;
      replacement, and a robust sandwich estimator will be used for the logistic regression&#xD;
      analyses in order to ensure correct variance estimation.&#xD;
&#xD;
      All available data will be used. Model assumptions will be checked. A p-value below or equal&#xD;
      to 0.05 will be considered significant. All analyses will be performed using R statistical&#xD;
      software, version 3.5.1 (R Foundation for Statistical Computing, Vienna, Austria).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2008</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of recurrence</measure>
    <time_frame>5.2 years</time_frame>
    <description>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&#xD;
- 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5.2 years</time_frame>
    <description>Death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-term mortality</measure>
    <time_frame>30 and 90 days</time_frame>
    <description>Death from any cause within 30 and 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postoperative complications</measure>
    <time_frame>60 days</time_frame>
    <description>Patients having surgical and non-surgical postoperative complications and with complications with Clavien-Dindo score of 3b or more</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mesocolic lymph nodes yield</measure>
    <time_frame>1 day</time_frame>
    <description>Median number of lymph nodes detected in the specimens and proportion of specimens with 22 or more lymph nodes detected</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">920</enrollment>
  <condition>Sigmoid Neoplasms</condition>
  <arm_group>
    <arm_group_label>CME group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-CME group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Complete mesocolic excision</intervention_name>
    <description>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.</description>
    <arm_group_label>CME group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional colon resection</intervention_name>
    <description>The patients underwent what was considered standard colon cancer resections in Denmark during the study period.</description>
    <arm_group_label>Non-CME group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data for all patients undergoing elective surgery for UICC stage I-III colonic&#xD;
        adenocarcinoma in the Capital Region of Denmark. The population of this region is&#xD;
        approximately 1⋅75 million, more than 30 per cent of the population of Denmark, and it is&#xD;
        served by only four public university colorectal cancer centres.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sigmoid colon cancer was defined as primary adenocarcinomas located in the sigmoid&#xD;
             colon (more than 15 cm from the anal verge)&#xD;
&#xD;
          -  UICC stage I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Synchronous colorectal cancer - even in the sigmoid colon&#xD;
&#xD;
          -  No residual tumor in the specimen after neoadjuvant chemotherapy&#xD;
&#xD;
          -  Metachronous colorectal cancer&#xD;
&#xD;
          -  Resections in Hillerød not performed according to the principles of CME&#xD;
&#xD;
          -  Non-macroradical (R2) resections (peroperative assessment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claus A Bertelsen, PhD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Surgery, Nordsjaellands Hospital Hillerød</affiliation>
  </overall_official>
  <reference>
    <citation>Rosenberg J, Fischer A, Haglind E; Scandinavian Surgical Outcomes Research Group. Current controversies in colorectal surgery: the way to resolve uncertainty and move forward. Colorectal Dis. 2012 Mar;14(3):266-9. doi: 10.1111/j.1463-1318.2011.02896.x.</citation>
    <PMID>22122825</PMID>
  </reference>
  <reference>
    <citation>West NP, Sutton KM, Ingeholm P, Hagemann-Madsen RH, Hohenberger W, Quirke P. Improving the quality of colon cancer surgery through a surgical education program. Dis Colon Rectum. 2010 Dec;53(12):1594-603. doi: 10.1007/DCR.0b013e3181f433e3.</citation>
    <PMID>21178852</PMID>
  </reference>
  <reference>
    <citation>Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.</citation>
    <PMID>19016817</PMID>
  </reference>
  <reference>
    <citation>Bokey L, Chapuis PH, Chan C, Stewart P, Rickard MJ, Keshava A, Dent OF. Long-term results following an anatomically based surgical technique for resection of colon cancer: a comparison with results from complete mesocolic excision. Colorectal Dis. 2016 Jul;18(7):676-83. doi: 10.1111/codi.13159.</citation>
    <PMID>26476136</PMID>
  </reference>
  <reference>
    <citation>Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.</citation>
    <PMID>25555421</PMID>
  </reference>
  <reference>
    <citation>Kotake K, Mizuguchi T, Moritani K, Wada O, Ozawa H, Oki I, Sugihara K. Impact of D3 lymph node dissection on survival for patients with T3 and T4 colon cancer. Int J Colorectal Dis. 2014 Jul;29(7):847-52. doi: 10.1007/s00384-014-1885-z. Epub 2014 May 6.</citation>
    <PMID>24798631</PMID>
  </reference>
  <reference>
    <citation>Olofsson F, Buchwald P, Elmstahl S, Syk I. High Tie or not in Resection for Cancer in the Sigmoid Colon? Scand J Surg. 2019 Sep;108(3):227-232. doi: 10.1177/1457496918812198. Epub 2018 Nov 21.</citation>
    <PMID>30458672</PMID>
  </reference>
  <reference>
    <citation>Bertelsen CA, Neuenschwander AU, Jansen JE, Kirkegaard-Klitbo A, Tenma JR, Wilhelmsen M, Rasmussen LA, Jepsen LV, Kristensen B, Gogenur I; Copenhagen Complete Mesocolic Excision Study (COMES); Danish Colorectal Cancer Group (DCCG). Short-term outcomes after complete mesocolic excision compared with 'conventional' colonic cancer surgery. Br J Surg. 2016 Apr;103(5):581-9. doi: 10.1002/bjs.10083. Epub 2016 Jan 18.</citation>
    <PMID>26780563</PMID>
  </reference>
  <reference>
    <citation>Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.</citation>
    <PMID>21818162</PMID>
  </reference>
  <reference>
    <citation>Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015 Dec 10;34(28):3661-79. doi: 10.1002/sim.6607. Epub 2015 Aug 3.</citation>
    <PMID>26238958</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colon cancer</keyword>
  <keyword>Surgery</keyword>
  <keyword>Oncological outcome</keyword>
  <keyword>Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Sigmoid Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774134
org study id: CMELoS2019
nct id: NCT03774134
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study based in existing databases investigating the causal oncological treatment effects of
      complete mesocolic excision on UICC stage I-III sigmoid colon cancer
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).
observational model: Cohort
time perspective: Prospective
measure: Risk of recurrence
time frame: 5.2 years
description: 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.
measure: Overall survival
time frame: 5.2 years
description: Death by any cause
measure: Short-term mortality
time frame: 30 and 90 days
description: Death from any cause within 30 and 90 days
measure: Rate of postoperative complications
time frame: 60 days
description: Patients having surgical and non-surgical postoperative complications and with complications with Clavien-Dindo score of 3b or more
measure: Mesocolic lymph nodes yield
time frame: 1 day
description: Median number of lymph nodes detected in the specimens and proportion of specimens with 22 or more lymph nodes detected
arm group label: CME group
description: 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.
arm group label: Non-CME group
description: 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.
intervention type: Procedure
intervention name: Complete mesocolic excision
description: 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.
arm group label: CME group
intervention type: Procedure
intervention name: Conventional colon resection
description: The patients underwent what was considered standard colon cancer resections in Denmark during the study period.
arm group label: Non-CME group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claus A Bertelsen, PhD, MD
role: Study Chair
affiliation: Department of Surgery, Nordsjaellands Hospital Hillerød
citation: Rosenberg J, Fischer A, Haglind E; Scandinavian Surgical Outcomes Research Group. Current controversies in colorectal surgery: the way to resolve uncertainty and move forward. Colorectal Dis. 2012 Mar;14(3):266-9. doi: 10.1111/j.1463-1318.2011.02896.x.
PMID: 22122825
citation: West NP, Sutton KM, Ingeholm P, Hagemann-Madsen RH, Hohenberger W, Quirke P. Improving the quality of colon cancer surgery through a surgical education program. Dis Colon Rectum. 2010 Dec;53(12):1594-603. doi: 10.1007/DCR.0b013e3181f433e3.
PMID: 21178852
citation: Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.
PMID: 19016817
citation: Bokey L, Chapuis PH, Chan C, Stewart P, Rickard MJ, Keshava A, Dent OF. Long-term results following an anatomically based surgical technique for resection of colon cancer: a comparison with results from complete mesocolic excision. Colorectal Dis. 2016 Jul;18(7):676-83. doi: 10.1111/codi.13159.
PMID: 26476136
citation: Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.
PMID: 25555421
citation: Kotake K, Mizuguchi T, Moritani K, Wada O, Ozawa H, Oki I, Sugihara K. Impact of D3 lymph node dissection on survival for patients with T3 and T4 colon cancer. Int J Colorectal Dis. 2014 Jul;29(7):847-52. doi: 10.1007/s00384-014-1885-z. Epub 2014 May 6.
PMID: 24798631
citation: Olofsson F, Buchwald P, Elmstahl S, Syk I. High Tie or not in Resection for Cancer in the Sigmoid Colon? Scand J Surg. 2019 Sep;108(3):227-232. doi: 10.1177/1457496918812198. Epub 2018 Nov 21.
PMID: 30458672
citation: Bertelsen CA, Neuenschwander AU, Jansen JE, Kirkegaard-Klitbo A, Tenma JR, Wilhelmsen M, Rasmussen LA, Jepsen LV, Kristensen B, Gogenur I; Copenhagen Complete Mesocolic Excision Study (COMES); Danish Colorectal Cancer Group (DCCG). Short-term outcomes after complete mesocolic excision compared with 'conventional' colonic cancer surgery. Br J Surg. 2016 Apr;103(5):581-9. doi: 10.1002/bjs.10083. Epub 2016 Jan 18.
PMID: 26780563
citation: Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
PMID: 21818162
citation: Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015 Dec 10;34(28):3661-79. doi: 10.1002/sim.6607. Epub 2015 Aug 3.
PMID: 26238958
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Sigmoid Neoplasms
sharing ipd: No