Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000324

Trial Description

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Title

Investigation of the analysis quality of PillCam Colon Capsule endoscopy of Doctors and Nurses compared to experts - RCT.

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Trial Acronym

[---]*

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URL of the Trial

http://-

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Brief Summary in Lay Language

The topic of the study is the investigation of the analysis quality of Colon capsule endoscopy of Doctors and endoscopy nurses compared to results of experts. (Golden Standard). Studies about small bowel capsule endoscopy (PillCam SB) have a high agreement between doctors and nurses (Bossa et al. [2006], Niv & Niv [2005] und Levinthal et al. [2003]; 85%, 96,9% bzw. 93%). A German or international study about the investigation of the analysis quality of PillCam Colon Capsule endoscopy with doctors and nurses compared to experts doesn`t exist yet. We form pairs of analysers in all 9 study centres. In every centre a doctor and a nurse interpret same 30 randomized colon capsule films. Participants are 9 physicians and 9 endoscopy nurses from several hospitals in Germany. The participants don`t know the results and don`t know who is he copartner of the pair. The primary endpoint of the study is the proof to a comparable high sensitivity. Secundary endpoints are:

a. comparison of the specifity of the detection of polyps of doctors and nurses comparing to the results of experts (Golden Standard).

b. comparison of the number of polyps between doctors and nurses

c. comparison of the polyp size (=> 10 mm) between doctors and nurses

d. comparison of the needed time for analysis between doctors and nurses

f. Comparison of the years of occupation and the number of both carried out and assisted colonoscopies between doctors and nurses

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Brief Summary in Scientific Language

The topic of the study is the investigation of the analysis quality of Colon capsule endoscopy of Doctors and endoscopy nurses compared to results of experts. (Golden Standard). Studies about small bowel capsule endoscopy (PillCam SB) have a high agreement between doctors and nurses (Bossa et al. [2006], Niv & Niv [2005] und Levinthal et al. [2003]; 85%, 96,9% bzw. 93%). A German or international study about the investigation of the analysis quality of PillCam Colon Capsule endoscopy with doctors and nurses compared to experts doesn`t exist yet. We formed pairs of analysers in all 9 study centres. In every centre a doctor and a nurse interpret same 30 randomized colon capsule films. Participants are 9 physicians and 9 endoscopy nurses from several hospitals in Germany. The participants don`t know the results and don`t know who is he other part of the pair. The primary endpoint of the study is the proof to a comparable high sensitivity. Secundary endpoints are:

a. comparison of the specifity of the detection of polyps of doctors and nurses comparing to the results of experts (Golden Standard).

b. comparison of the number of polyps between doctors and nurses

c. comparison of the polyp size (=> 10 mm) between doctors and nurses

d. comparison of the needed time for analysis between doctors and nurses

f. Comparison of the years of occupation and the number of both carried out and assisted colonoscopies between doctors and nurses


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Organizational Data

  •   DRKS00000324
  •   2010/05/25
  •   [---]*
  •   yes
  •   Approved
  •   HRB 5865, International Medical and Dental Ethics Commission GmbH Freiburg im Breisgau
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Secondary IDs

  •   U1111-1115-0107 
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Health Condition or Problem studied

  •   Analysis of interpretation quality of PillCam Colon- Capsule endoscopy films by different medical staff compared to experts
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Interventions/Observational Groups

  •   Group A include 9 endoscopy nurses or nurse assistants who assisted at least 300 colonoscopies independent. All 9 study participants in group
    A have to analyse 30 randomized capsule endoscopy films.
  •   Group B include 9 physicians who have done at least 300 colonoscopies independent. All study participants in group B have to analyse 30 randomized capsule endoscopy films.

    Interpretation pairs have been buildt between group A and B. So every pair analyse the same 30 randomized films but not in the same centre.
  •   The Golden Standard is the documentated result of the interpretation of colon capsule endoscopy by 14 experts from several european countries.
    All 14 experts are internists and gastroenterologists and have done at least 500 colonoscopies independent. They have experience in capsule endoscopy and have got a special training in colon capsule endoscopy.
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Characteristics

  •   Non-interventional
  •   Other
  •   Randomized controlled trial
  •   Single blind
  •   [---]*
  •   Active control
  •   Diagnostic
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

The primary endpoint of the study is the proof to a comparable high sensitivity between nurses and physicians compared to experts.

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Secondary Outcome

Secundary endpoints are:

a. comparison of the specifity of the detection of polyps of doctors and nurses comparing to the results of experts (Golden Standard).

b. comparison of the number of polyps between doctors and nurses

c. comparison of the polyp size (=> 10 mm) between doctors and nurses

d. comparison of the needed time for analysis between doctors and nurses

f. Comparison of the years of occupation and the number of both carried out and assisted colonoscopies between doctors and nurses

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/05/25
  •   18
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Included have been nurses who should have completed further education in endoscopy nursing and physicians who should be at least general practitioner (internist). Both staff should have experience with at least or more 300 colonoscopies which should be done independent and both staff groups shouldn`t have experience in capsule endoscopy

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Exclusion Criteria

Excluded have been nurses who do not have further education in endoscopy nursing and who
physicians do not have an examen for general practitioner (internist). Both staff groups have less experience then 300 colonoscopies and have already experience in capsule endoscopy

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Addresses

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    • Stiftung Evengelisches Krankenhaus Düsseldorf
    • Kirchfeldstr. 40
    • 40217   Düsseldorf
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Stiftung Evengelisches Krankenhaus
    • Ms.  Ute  Pfeifer 
    • Kirchfeldstr. 40
    • 40217  Düsseldorf
    • Germany
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    • Stiftung Evangelisches Krankenhaus Düsseldorf
    • Ms.  Ute  Pfeifer 
    • Kirchfeldstr. 40
    • 40217   Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Given Imaging GmbH EMEA Headquarters Given Imaging Ltd. New Industrial Park Yoqneam/ Israel
    • Mr.  Dr. rer. nat.  Manfred  Gehrtz 
    • Borsteler Chaussee 47
    • 22453  Hamburg
    • Germany
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    • Stiftung Evangelisches Krankenhaus
    • Mr.  Prof.Dr.med.  Horst  Neuhaus 
    • Kirchfeldstr. 40
    • 40217   Düsseldorf
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   [---]*
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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.