Evolution of Corporeal Composition in the PeriOperative Period (ECCOP)
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|ClinicalTrials.gov Identifier: NCT02143869|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2014
Last Update Posted : April 26, 2017
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).
|Condition or disease||Intervention/treatment|
|Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal) Lung Cancer||Device: Bioelectrical Impedance Analysis|
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|
|Actual Enrollment :||374 participants|
|Official Title:||Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2018|
Device: Bioelectrical Impedance Analysis
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143869
|Hôpital Européen Marseille|
|Principal Investigator:||Jérôme ALLARDET-SERVENT, MD, MSc||Hôpital Européen Marseille|