Trial document




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  DRKS00017762

Trial Description

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Title

Influence of dental health status and oral microbiome on postoperative outcome after lung surgery

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Trial Acronym

ZPTL

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URL of the Trial

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Brief Summary in Lay Language

In last decades, significant improvements in the field of intensive care therapies have enabled more complex and invasive thoracic surgery. Nevertheless, morbidity and mortality after anatomical lung resection remains a relevant problem in daily clinical routine. One of the most common causes of increased morbidity and mortality are pulmonary complications. A reliable predictor of morbidity after lung resection for better patient selection has not yet been identified. A reliable assessment of the post-operative risk remains a largely unresolved challenge. In an attempt to perform a valid preoperative selection of the patients qualifying for thoracic surgery, various risk assessment parameters were examined. Due to high prevalence of pulmonary complications in the postoperative course, previous studies focused on pulmonary function parameters. In addition to pulmonary complications, cardiovascular complications, and „systemic“ complications like the systemic inflammatory response syndrome (SIRS) or the acute respiratory distress syndrome (ARDS) are feared. For all these organ-related and systemic complications at least a systemic inflammatory trigger is postulated. Experimental work could establish a relationship between inflammation and surgical outcome. The aim of the present study is therefore to examine the dental status of the patient as a possible source of infection and thus cause for postoperative complications. The special focus of the study is on pneumonia and other infection-associated complications.

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Brief Summary in Scientific Language

In recent years, further developments in anesthetic and intensive care medicine have offered many patients ever better surgical therapies. It was also possible to significantly reduce the rate of complications. Nevertheless, many complications are still part of everyday medical practice. An important complication after chest surgery is pneumonia and its consequences. Previous investigations could not reveal any cause of this important complication. From other fields of medicine one can assume that here the teeth and the oral cavity play an important role. Dental health, can affect not only postoperative pneumonia but also other complications. In this study, we would like to examine the influence of dental health and bacteria naturally present in the oral cavity on the occurrence of postoperative complications. Interestingly, an association between a pathological dental status or a pathological oral flora and the increased occurrence of postoperative pneumonia in neurosurgical patients could be demonstrated. An increased occurrence of exacerbations in COPD patients with poor dental status could also be observed. Improvement of dental health also reduced the risk of exacerbation. A link between lung function and dental status could also be demonstrated. Interestingly, it has even been shown that teeth brushing before esophagectomy significantly reduces the rate of postoperative pneumonia. So far, however, there are no data regarding the postoperative outcome after thoracic surgery and the dental status of the patient. Exceptions are a few publications on lung transplantation and dental status, but with a completely different immunological setting and that, these can not be compared with oncological patients.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017762
  •   2019/09/17
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  •   yes
  •   Approved
  •   17-7822-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   C34.0 -  Malignant neoplasm: Main bronchus
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Interventions/Observational Groups

  •   Correlation of oral Health Status with postsurgical outcome
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Correlation between dental health care status and postoperative complications after lung surgery.

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Secondary Outcome

Change of microbiome of the oral cavaty and the lung during therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/10/02
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Informed Consens
planned lung surgery

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Exclusion Criteria

patients younger than 18 years or older than 99 years

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Addresses

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    • Ruhrlandklinik Essen GmbH
    • Mr.  Dr.med  Till  Plönes 
    • Tüschener Weg 40
    • 45219  Essen
    • Germany
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    • Ruhrlandklinik Essen GmbH
    • Mr.  Dr.med  Till  Plönes 
    • Tüschener Weg 40
    • 45219  Essen
    • Germany
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    • Ruhrlandklinik Essen GmbH
    • Mr.  Dr.med  Till  Plönes 
    • Tüschener Weg 40
    • 45219  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Ruhrlandklinik Essen GmbH
    • Mr.  Dr.med  Till  Plönes 
    • Tüschener Weg 40
    • 45219  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/04/25
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.