Viewing Study NCT02799251


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Study NCT ID: NCT02799251
Status: COMPLETED
Last Update Posted: 2021-01-20
First Post: 2016-06-10
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Organization:

Study Overview

Official Title: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study
Status: COMPLETED
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EVALYMPH
Brief Summary: Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.
Detailed Description: Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis.

The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery. It is a multicenter French cohort study. Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery before surgery (day-0) as well 1, 3, 5 and 8 days after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: