Trial document




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  DRKS00006340

Trial Description

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Title

Nutritional Risk in Major Abdominal Surgery (Pancreas)

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Trial Acronym

NURIMAS Pancreas

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients scheduled for pancreatic surgery will be screened for malnutrition by screeining scores. After the operation it will be evaluated which score predicts best complications.

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Brief Summary in Scientific Language

Patients scheduled for pancreatic surgery will be screened for malnutrition by the following screeining scores: Nutritional Risk Index, Nutritional Risk Screening Score, Subjective Global Assessment, Malnutrition Universal Screening Tool, Mini Nutritional Assessment, Short Nutritional Assessment Questionnaire, Imperial Nutritional Screening System und Nutritional Risk Classification.
Postoperative morbidity and mortality will be recorded and predictive value of each score will be calculated.

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Organizational Data

  •   DRKS00006340
  •   2014/07/15
  •   [---]*
  •   yes
  •   Approved
  •   S-170/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Malnutrition in patients undergoing pancreatic surgery
  •   E43 -  Unspecified severe protein-energy malnutrition
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Interventions/Observational Groups

  •   Patients scheduled for pancreatic surgery are screened according to following scores: Nutritional Risk Index, Nutritional Risk Screening Score, Subjective Global Assessment, Malnutrition Universal Screening Tool, Mini Nutritional Assessment, Short Nutritional Assessment Questionnaire, Imperial Nutritional Screening System and Nutritional Risk Classification.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Blinded
  •   assessor
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Predective value of each score for postoperative Morbidity and mortality

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Secondary Outcome

Association of each score with length of hospital stay (ICU and normal ward); Place of discharge; Need for nutritional intervention; Case costs (DRG)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/08/07
  •   260
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Scheduled pancreatic surgery

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Exclusion Criteria

Re-operation of pancreas e.g. total pancreatectomy after Whipple; Minors or not able to give informed consent

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Dr. med., MSc  Pascal  Probst 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Dr. med., MSc  Pascal  Probst 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinisches Studienzentrum Chirurgie
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/21
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Trial Publications, Results and other Documents

  •   Br J Surg. 2017 Jul;104(8):1053-1062. doi: 10.1002/bjs.10525. Epub 2017 Mar 30
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* This entry means the parameter is not applicable or has not been set.