NCT03754075

Brief Summary

Study based on existing databases investigating the causal oncological treatment effects of complete mesocolic excision on UICC stage I-III right-sided colon cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,069

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2019

Completed
Last Updated

March 13, 2019

Status Verified

December 1, 2018

Enrollment Period

10.7 years

First QC Date

November 22, 2018

Last Update Submit

March 11, 2019

Conditions

Colonic Neoplasms

Keywords

Colon cancerSurgeryOncological outcomeSurvival

Outcome Measures

Primary Outcomes (1)

  • Risk of recurrence

    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 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.

    5.2 years

Secondary Outcomes (4)

  • Overall survival

    5.2 years

  • Short-term mortality

    30 and 90 days

  • Rate of postoperative complications

    60 days

  • Number of mesocolic lymph nodes

    1 day

Study Arms (2)

CME group

The CME group consisted of patients, who underwent elective CME for right-sided colon adenocarcinoma at Nordsjaellands Hospital Hillerød from 1 June 2008 to 31 December 2013.

Procedure: Complete mesocolic excision

Non-CME group

The non-CME group comprised patients having a elective conventional colon cancer resection for right-sided adenocarcinoma at the other three colorectal centers in the Capital Region of Denmark from 1 June 2008 to 31 December 2013.

Procedure: Conventional colon resections

Interventions

Complete mesocolic excisionPROCEDURE

The resection was based on the principles of CME. The superior mesenteric vein was exposed to perform central vessel ligation and lymph nodes dissection. Extended right hemicolectomies for tumors located from the ascending colon close to the hepatic flexure and distally were performed openly as standard during the study period. These resections included the prepyloric and gastroepiploic lymph nodes dissection.

CME group
Conventional colon resectionsPROCEDURE

The patients underwent what was considered standard colon cancer resections in Denmark during the study period.

Non-CME group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Right-sided colon cancer was defined as primary adenocarcinomas located in the cecum, ascending colon hepatic flexure, right or mid third of the transverse colon.
  • UICC stage I-III - Gastroepiploic and infrapyloric lymph node metastases are not considered as distant metastases

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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: 22122825BACKGROUND

  • 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: 21178852BACKGROUND

  • Lee L, Erkan A, Alhassan N, Kelly JJ, Nassif GJ, Albert MR, Rt Monson J. Lower survival after right-sided versus left-sided colon cancers: Is an extended lymphadenectomy the answer? Surg Oncol. 2018 Sep;27(3):449-455. doi: 10.1016/j.suronc.2018.05.031. Epub 2018 May 29.

    PMID: 30217301BACKGROUND

  • 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: 26476136BACKGROUND

  • 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: 19016817BACKGROUND

  • 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: 25555421BACKGROUND

  • 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: 24798631BACKGROUND

  • 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: 26780563BACKGROUND

  • 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: 21818162BACKGROUND

  • 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: 26238958BACKGROUND

  • Wal WM van der, Geskus RB. ipw : An R Package for Inverse Probability Weighting. J Stat Softw 43(13):1-23, 2011.

    BACKGROUND

  • Bernhoff R. Colon cancer aspects on surgical treatment and complete mesocolic excision. PhD thesis. Stockholm 2018. ISBN 978-91-7676-919-5.

    BACKGROUND

  • Bertelsen CA, Neuenschwander AU, Jansen JE, Tenma JR, Wilhelmsen M, Kirkegaard-Klitbo A, Iversen ER, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Born PW, Kristensen B, Kleif J. 5-year outcome after complete mesocolic excision for right-sided colon cancer: a population-based cohort study. Lancet Oncol. 2019 Nov;20(11):1556-1565. doi: 10.1016/S1470-2045(19)30485-1. Epub 2019 Sep 13.

    PMID: 31526695DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Claus A Bertelsen, PhD, MD

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Colorectal Surgeon, Head of Research

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 27, 2018

Study Start

June 1, 2008

Primary Completion

January 31, 2019

Study Completion

March 16, 2019

Last Updated

March 13, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share