Trial document





This trial has been registered retrospectively.
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  DRKS00007768

Trial Description

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Title

Incidence and risk factors for sedation-associated complications in gastrointestinal endoscopy — a prospective, multicenter electronic registry of the Hospital Gastroenterology Consultants Working Group (Arbeitsgemeinschaft Leitender Gastroenterologischer Klinikärzte, ALGK): ProSed II Study

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Trial Acronym

ProSed2

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Administering sedation is an established standard practice in gastrointestinal endoscopy. Sedation is unquestionably associated with a certain risk of complications. The data so far published on sedation-associated complications are limited, in the majority of cases derived from studies including only small numbers of patients and with clear methodological weaknesses.The aim of the present study was to record the incidence and type of sedation-associated complications. Risk factors were also to be identified. Sedation-associated complications were recorded and documented with computer support, using the input template of an endoscopy documentation system (E&L Ltd., Erlangen, Germany) that only allows an examination to be entered as complete if the sedation form has been filled out — ensuring 100% data recording.

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Organizational Data

  •   DRKS00007768
  •   2015/09/02
  •   [---]*
  •   yes
  •   Approved
  •   FF 8/2012, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   Sedation in GI-endoscopy
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Interventions/Observational Groups

  •   Sedation-associated complications are recorded and documented with computer support, using the input template of an endoscopy documentation system (E&L Ltd., Erlangen, Germany).
    The following data has to be filled out: ASA-classification, type of endoscopy, duration of the examination, sedation by NAPS yes/no, anesthesiologist yes/no, sedation medication/dosage, sedation-associated complication, complication management, long-term harms.
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Characteristics

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

Incidence and type of sedation-associated complications in gastrointestinal endoscopy

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Secondary Outcome

Identification of risk-factors for sedation-associated complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   Actual
  •   2012/12/01
  •   300000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   120   Years
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Additional Inclusion Criteria

Every examination (GI endoscopy) in sedation

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Exclusion Criteria

Every examination (GI endoscopy) without sedation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Sana Klinikum Offenbach
    • Mr.  Prof. Dr.  Christian  Ell 
    • Starkenburg Ring 66
    • 63069  Offenbach
    • Germany
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    • Vivantes Klinikum im Friedrichshain
    • Ms.  Dr.  Angelika  Behrens 
    • Landsberger allee 49
    • 10249  Berlin
    • Germany
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    • Vivantes Klinikum im Friedrichshain
    • Ms.  Dr.  Angelika  Behrens 
    • Landsberger Allee 49
    • 10249  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Fa. E&L medical systems GmbH
    • Wetterkreuz 19
    • 91058  Erlangen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Sana Klinikum Offenbach
    • Mr.  Prof.  Christian  Ell 
    • Starkenburgring 66
    • 63069  Offenbach
    • Germany
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Status

  •   Recruiting ongoing
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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.