ECCOP: Evolution of Corporeal Composition in the PeriOperative Period

• Sponsor: Hôpital Européen Marseille (Other)
• Overall Status: Completed
• CT.gov ID: NCT02143869
• Collaborator: (none)
• Enrollment: 374
• Location: 1
• Actual Duration (Months): 69
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal); Lung Cancer	Device: Bioelectrical Impedance Analysis

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 Design

• Study Type: Observational
• Actual Enrollment: 374 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Sep 1, 2019

Outcome Measures

Primary Outcome Measures

1. 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

1. perioperative complications [6 months]

   One of the secondary objective is to investigate the relationship between baseline body composition and the occurrence of surgical complications.

Other Outcome Measures

1. nutritional intake during perioperative period [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 [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. [6 months]

   One of the secondary objective is to compare the body composition obtained by Bioelectrical Impedance Analysis (BIA) and by anthropometric measurements.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Européen Marseille	Marseille		France

Sponsors and Collaborators

• Hôpital Européen Marseille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille
• ClinicalTrials.gov Identifier: NCT02143869
• Other Study ID Numbers: 2013-A01346-39
• First Posted: May 21, 2014
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille: Gastrointestinal cancer; Lung cancer; Bioelectrical Impedance analysis; Body composition; Perioperative
• Additional relevant MeSH terms: Lung Neoplasms; Gastrointestinal Neoplasms

Study Results

No Results Posted as of Sep 4, 2019