BMI and Lymph Node Count in Colorectal Cancer

March 21, 2024 updated by: Dr. Tamara Braunschmid, Klinikum Floridsdorf

Prediction of Survival in Colorectal Cancer Patients on the Basis of Body Mass Index and Lymph Node Yield - a Retrospective Single Center Cohort Analysis Over a Quarter of a Century

Background and aim: Colorectal Cancer (CRC) is one of the most frequent cancer entities in the western world. It is known that obesity is one of the major risk factors for CRC. In contrast, mild obesity seems to have a positive effect on postoperative outcome, which is known as the "obesity paradox". Also, the number of resected lymph nodes (LN) during surgery is very important for correct staging. The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.

Methods: Patients treated for CRC between 1998 and 2011 at the Klinik Favoriten in Vienna, Austria were analyzed in this retrospective single-center cohort analysis concerning OS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1210
        • Klinik Floridsdorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who had surgery at the department of surgery at the Klinik Favoriten between 1998 and 2011 were analyzed. 1192 patients met the inclusion criteria were therefore pseudonymized and recorded in a newly developed database.

Description

Inclusion Criteria:

  • colorectal carcinoma
  • treated at the Klinik Favoriten between 1998 and 2011
  • elective or acute surgical setting
  • curative intent
  • older than 18 years

Exclusion Criteria:

  • other carcinoma (anal, metastases, ...)
  • treated before 1998 or after 2011
  • palliative intent
  • younger than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colon cancer patients
Retrospective data analysis of the subgroup of patients suffering from colon carcinoma
Other: no intervention, retrospective data analysis
not applicable, retrospective data analysis
Rectal cancer patients
Retrospective data analysis of the subgroup of patients suffering from rectal carcinoma
Other: no intervention, retrospective data analysis
not applicable, retrospective data analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: median follow up of 11.3 years
The aim of the present project is to evaluate the impact of BMI and LN-yield on long term overall survival (OS) of CRC patients treated with curative intent.
median follow up of 11.3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Floridsdorf

Collaborators

Medical University of Vienna
Klinik Favoriten
Salzkammergut Klinikum Vöcklabruck

Investigators

  • Principal Investigator: Tamara Braunschmid, MD, Klinik Floridsdorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 18-002-VK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All relevant data will be shared within a publication of the study. Detailled data are available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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