Trial document





This trial has been registered retrospectively.
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  DRKS00000128

Trial Description

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Title

Prospective trial comparing Spiral enteroscopy and Double Balloon enteroscopy (DBE) in patients with small bowel disorders

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The Spiral enteroscopy was developed to reduce the examination-time in small bowel endoscopy. The special overtube has been used since 2006 in the United States, initially to optimize the colonoskopie. Positive experiences within small bowel endoscopy also exist. The average examination time was 26 and 29 minutes, which is a very significant reduction in mean investigation time. The average depth was about 250 cm, would be comparable to the double balloon endoscopy. However, there are no standardized measurement method to evaluate the deapth of insertion. Serious complications were not reported.
The aim of this study is to compare these two techniques under study conditions.

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Brief Summary in Scientific Language

The Spiral enteroscopy was developed to reduce the examination-time in small bowel endoscopy. The special overtube has been used since 2006 in the United States, initially to optimize the colonoskopie. Positive experiences within small bowel endoscopy also exist. The average examination time was 26 and 29 minutes, which is a very significant reduction in mean investigation time. The average depth was about 250 cm, would be comparable to the DBE. However, there are no standardized measurement method to evaluate the deapth of insertion. Serious complications were not reported.
The aim of this study is to compare these two techniques under prospective study conditions.

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Organizational Data

  •   DRKS00000128
  •   2009/06/09
  •   [---]*
  •   yes
  •   Approved
  •   FF 66/2008, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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

  •   suspected or known small bowel disorder
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Interventions/Observational Groups

  •   1. spiral enteroscopy, 2. double balloon enteroscopy
  •   1. DBE, 2. Spiralenteroscopy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Crossover
  •   [---]*
  •   [---]*
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Primary Outcome

duration of investigation, acquisition by questionaire

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2008/10/17
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria had been suspected or known small bowel disorder for diagnostic balloon enteroscopy or therapeutic enteroscopy

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Exclusion Criteria

lack of consent, pregnancy, coagulation disorders (thrombocytes < 100000/ml, Quick < 60%, PTT > 50 s), prior complex surgery of the small bowel and colon, sufficient findings and objective investigation in first enteroscopy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik Innere Medizin II Horst-Schmidt-Kliniken Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Klinik für Innere Medizin II
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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    • Klinik Innere Medizin II Horst-Schmidt-Kliniken Wiesbaden
    • Mr.  Dr. med.  Michael  Färber 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • Klinik Innere Medizin II Horst-Schmidt-Kliniken Wiesbaden
    • Ms.  Dr. med.  Andrea  May 
    • Ludwig-Erhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/06/15
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Trial Publications, Results and other Documents

  •   Endoscopy. 2011 Jun;43(6):477-83. Epub 2011 Mar 24. Prospective, cross-over, single-center trial comparing oral double-balloon enteroscopy and oral spiral enteroscopy in patients with suspected small-bowel vascular malformations. May A, Manner H, Aschmoneit I, Ell C.
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* This entry means the parameter is not applicable or has not been set.