Evolution of Corporeal Composition in the PeriOperative Period (ECCOP)

September 3, 2019 updated by: Jerome Allardet-Servent, MD, Hôpital Européen Marseille

Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery

Denutrition and Obesity are risk factors for perioperative surgical complications.

In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition.

In this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis (BIA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Body composition measurements will be performed before surgical procedure (7 days) and at day 1, day 5, 1 month, 3 months and 6 months after surgery.

Others data will be recorded including anthropometric measurements, nutritional intake, occurence of surgical complication, type of surgical procedure, type and stage of cancer, and CT-scan measurements of subcutaneous abdominal fat, visceral fat and peri-renal fat before surgery and at 6 months.

Study Type

Observational

Enrollment (Actual)

374

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

  • France
      • Marseille, France
        • Hôpital Européen Marseille

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal) or lung cancer undergoing curative surgical resection as part of their disease management.

Description

Inclusion Criteria:

  • Gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal)
  • Or Lung cancer
  • And planned surgical resection
  • Age > 18 years

Exclusion Criteria:

  • Surgical procedure planned < 48 h
  • Pregnancy
  • Presence of a cardiac stimulator

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition
Time Frame: 1 month
The primary objective is to study the change in body composition (fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water) during the perioperative period with respect to short, mid and long term outcome.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative complications
Time Frame: 6 months
One of the secondary objective is to investigate the relationship between baseline body composition and the occurrence of surgical complications.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
nutritional intake during perioperative period
Time Frame: 1 month
One of the secondary objective is to investigate the relationship between change in body composition and perioperative nutritional intake.
1 month
cancer type and stage
Time Frame: 6 months
One of the secondary objective is to investigate the relationship between baseline body composition and the type and stage of cancer.
6 months
comparison of the body composition obtained by BIA and anthropometric measurements.
Time Frame: 6 months
One of the secondary objective is to compare the body composition obtained by Bioelectrical Impedance Analysis (BIA) and by anthropometric measurements.
6 months

Collaborators and Investigators

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

Sponsor

Hôpital Européen Marseille

Investigators

  • Principal Investigator: Jérôme ALLARDET-SERVENT, MD, MSc, Hôpital Européen Marseille

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, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

May 18, 2014

First Submitted That Met QC Criteria

May 18, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01346-39

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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