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Completed

NCT Number: NCT02143869

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).

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Key information

Conditions

Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal) Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Européen Marseille

Marseille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioelectrical Impedance Analysis

Device

Measurements of body composition including fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Official study title

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

Acronym: ECCOP

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
May 21, 2014
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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