Evolution Of Corporeal Composition In The PeriOperative Period

Study Overview

Evolution of Corporeal Composition in the PeriOperative Period

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).

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.

Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal)
Lung Cancer

DEVICE: Bioelectrical Impedance Analysis

2013-A01346-39

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-05-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-09-03
First Submitted that Met QC Criteria 2014-05-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-04
First Posted (ACTUAL) 2014-05-21	Results First Posted N/A	Last Verified 2019-09

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Jérôme ALLARDET-SERVENT, MD, MSc, Hôpital Européen Marseille

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record