Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections (EVALYMPH)

January 15, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne

Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • CHU Angers
      • Caen, France, 14003
        • Hôpital Côtes de Nacre CHU CAEN
      • Clermont-Ferrand, France, 63100
        • Hôpital Estaing CHU CLERMONT-FERRAND
      • Clichy, France, 92110
        • Hôpital Beaujon CHU PARIS 1
      • La Tronche, France, 38700
        • Hôpital Michallon CHU GRENOBLE
      • Lille, France, 59037
        • Hôpital Huriez CHRU LILLE
      • Lyon, France, 69000
        • Hôpital Edouard Herriot CHU LYON
      • Lyon, France, 69000
        • Hôpital La croix Rousse CHU LYON
      • Lyon, France, 69000
        • Hôpital Lyon Sud CHU LYON
      • Marseille, France, 13015
        • Hôpital Nord CHU MARSEILLE
      • Marseille, France, 13385
        • Hôpital La Timone CHU MARSEILLE
      • Nantes, France, 44000
        • Hôpital Hôtel-Dieu CHU NANTES
      • Nîmes, France, 30029
        • Hôpital Carémeau CHU NIMES
      • Paris, France, 75010
        • Hôpital Saint Louis-Lariboisière CHU PARIS 5
      • Paris, France, 75012
        • Hôpital Saint-Antoine CHU PARIS 4
      • Paris, France, 75013
        • Hôpital La pitié-Salpetrière CHU PARIS 3
      • Paris, France, 75018
        • Hôpital Bichat CHU PARIS 2
      • Rennes, France, 35000
        • Hôpital Pontchaillou CHU RENNES
      • Strasbourg, France, 67000
        • Hôpital Central CHRU STRASBOURG
      • Toulouse, France, 31000
        • Centre de Lutte contre le Cancer, TOULOUSE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia.

Description

Inclusion Criteria:

  • patient undergoing digestive or thoracic cancer surgery under general anesthesia.

Exclusion Criteria:

  • pregnant women,
  • malignant blood disease,
  • allograft patient,
  • preoperative sepsis or preoperative systemic inflammatory response syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Collection of plasma cell rate
Post operative infections and their association with lymphopenia are assessed in this study for patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia.
Other: Collection of plasma cell rate
Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery. The rates are assessed before surgery (day 0) and at days 1, 3, 5 and 8 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of post operative infection
Time Frame: 1 month
Patients undergoing general anesthesia for thoracic or digestive surgery could present lymphopenia. In this situation, the presence of post operative infection is notified. The correlation between lymphopenia and post operative infections is studied.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthetic and surgical parameters
Time Frame: 1 month
To identify anesthetic and surgical parameters influencing postoperative lymphocytes cells count.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Serge Molliex, PhD, CHU de SAINT-ETIENNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1600010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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