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Completed

NCT Number: NCT02799251

Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Angers, Angers, France

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About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of plasma cell rate

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Anesthetic and surgical parameters

    Time frame: 1 month

    To identify anesthetic and surgical parameters influencing postoperative lymphocytes cells count.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: EVALYMPH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2016
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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