Evolution of Corporeal Composition in the PeriOperative Period

Completed

• Conditions: Lung Cancer; Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal)

• Registration Number: NCT02143869
• Lead Sponsor: Hôpital Européen Marseille

Brief Summary

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).

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-05-18
• Study First Submitted QC: 2014-05-18
• Study First Posted: 2014-05-21
• Primary Completion: 2016-12
• Status Verified: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
body composition	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 Outcome Measures

Name	Time	Method
perioperative complications	6 months	One of the secondary objective is to investigate the relationship between baseline body composition and the occurrence of surgical complications.

Trial Locations

Locations (1)

Hôpital Européen Marseille; 🇫🇷 Marseille, France