Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections

Completed

• Conditions: Thoracic Diseases; Cancer of the Digestive System

• Registration Number: NCT02799251
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-14
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of post operative infection	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.

Secondary Outcome Measures

Name	Time	Method
Anesthetic and surgical parameters	1 month	To identify anesthetic and surgical parameters influencing postoperative lymphocytes cells count.

Trial Locations

Locations (20)

Chu Angers; 🇫🇷 Angers, France

Hôpital Côtes de Nacre CHU CAEN; 🇫🇷 Caen, France

Hôpital Estaing CHU CLERMONT-FERRAND; 🇫🇷 Clermont-Ferrand, France

Hôpital Beaujon CHU PARIS 1; 🇫🇷 Clichy, France

Hôpital Michallon CHU GRENOBLE; 🇫🇷 La Tronche, France

Hôpital Huriez CHRU LILLE; 🇫🇷 Lille, France

Hôpital Edouard Herriot CHU LYON; 🇫🇷 Lyon, France

Hôpital La croix Rousse CHU LYON; 🇫🇷 Lyon, France

Hôpital Lyon Sud CHU LYON; 🇫🇷 Lyon, France

Hôpital Nord CHU MARSEILLE; 🇫🇷 Marseille, France

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