Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections

NCT ID: NCT02799251

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Cancer of the Digestive System Thoracic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Collection of plasma cell rate

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serge Molliex, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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Chu Angers

Angers, , France

Site Status

Hôpital Côtes de Nacre CHU CAEN

Caen, , France

Site Status

Hôpital Estaing CHU CLERMONT-FERRAND

Clermont-Ferrand, , France

Site Status

Hôpital Beaujon CHU PARIS 1

Clichy, , France

Site Status

Hôpital Michallon CHU GRENOBLE

La Tronche, , France

Site Status

Hôpital Huriez CHRU LILLE

Lille, , France

Site Status

Hôpital Edouard Herriot CHU LYON

Lyon, , France

Site Status

Hôpital La croix Rousse CHU LYON

Lyon, , France

Site Status

Hôpital Lyon Sud CHU LYON

Lyon, , France

Site Status

Hôpital Nord CHU MARSEILLE

Marseille, , France

Site Status

Hôpital La Timone CHU MARSEILLE

Marseille, , France

Site Status

Hôpital Hôtel-Dieu CHU NANTES

Nantes, , France

Site Status

Hôpital Carémeau CHU NIMES

Nîmes, , France

Site Status

Hôpital Saint Louis-Lariboisière CHU PARIS 5

Paris, , France

Site Status

Hôpital Saint-Antoine CHU PARIS 4

Paris, , France

Site Status

Hôpital La pitié-Salpetrière CHU PARIS 3

Paris, , France

Site Status

Hôpital Bichat CHU PARIS 2

Paris, , France

Site Status

Hôpital Pontchaillou CHU RENNES

Rennes, , France

Site Status

Hôpital Central CHRU STRASBOURG

Strasbourg, , France

Site Status

Centre de Lutte contre le Cancer, TOULOUSE

Toulouse, , France

Site Status

Countries

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France

References

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Petit L, Pastene B, Dupont G, Baffeleuf B, Goulevant PA, Fellahi JL, Gricourt Y, Lebuffe G, Ouattara A, Fischer MO, Mertes PM, Eyraud D, Bouhemad B, Gomola A, Montravers P, Alingrin J, Flory L, Incagnoli P, Boisson M, Leone M, Monneret G, Lukaszewicz AC, Pereira B, Molliex S; for the EVALYMPH study group. Postoperative lymphopaenia as a risk factor for postoperative infections in cancer surgery: A prospective multicentre cohort study (the EVALYMPH study). Eur J Anaesthesiol. 2025 Mar 1;42(3):244-254. doi: 10.1097/EJA.0000000000002089. Epub 2024 Oct 29.

Reference Type DERIVED
PMID: 39474711 (View on PubMed)

Other Identifiers

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1600010

Identifier Type: -

Identifier Source: org_study_id

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