Clinical trial NCT02799251: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections
Official title: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Digestive System
Thoracic Diseases
Keywords: lymphopenia
postoperative infection
thoracic cancer surgery
digestive cancer surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 1125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of post operative infection
timeFrame: 1 month
Secondary outcomes:
measure: Anesthetic and surgical parameters
timeFrame: 1 month
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Caen
country: France
facility: Hôpital Côtes de Nacre CHU CAEN
city: Clermont-Ferrand
country: France
facility: Hôpital Estaing CHU CLERMONT-FERRAND
city: Clichy
country: France
facility: Hôpital Beaujon CHU PARIS 1
city: La Tronche
country: France
facility: Hôpital Michallon CHU GRENOBLE
city: Lille
country: France
facility: Hôpital Huriez CHRU LILLE
city: Lyon
country: France
facility: Hôpital Edouard Herriot CHU LYON
city: Lyon
country: France
facility: Hôpital La croix Rousse CHU LYON
city: Lyon
country: France
facility: Hôpital Lyon Sud CHU LYON
city: Marseille
country: France
facility: Hôpital Nord CHU MARSEILLE
city: Marseille
country: France
facility: Hôpital La Timone CHU MARSEILLE
city: Nantes
country: France
facility: Hôpital Hôtel-Dieu CHU NANTES
city: Nîmes
country: France
facility: Hôpital Carémeau CHU NIMES
city: Paris
country: France
facility: Hôpital Saint Louis-Lariboisière CHU PARIS 5
city: Paris
country: France
facility: Hôpital Saint-Antoine CHU PARIS 4
city: Paris
country: France
facility: Hôpital La pitié-Salpetrière CHU PARIS 3
city: Paris
country: France
facility: Hôpital Bichat CHU PARIS 2
city: Rennes
country: France
facility: Hôpital Pontchaillou CHU RENNES
city: Strasbourg
country: France
facility: Hôpital Central CHRU STRASBOURG
city: Toulouse
country: France
facility: Centre de Lutte contre le Cancer, TOULOUSE
Study officials:
affiliation: CHU de Saint-Etienne
name: Serge Molliex, PhD
role: PRINCIPAL_INVESTIGATOR
References: