Trial document





This trial has been registered retrospectively.
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  DRKS00006154

Trial Description

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Title

Anorectal manometry study for normative data in different age groups

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This study aims to collect normative data for anorectal manometry with solid-state probes in different age groups. Children from age 0 - 14 with no prior history of constipation, abdominal surgery or other problems affecting the gastrointestinal tract were included.

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Brief Summary in Scientific Language

This study aims to collect normative data for anorectal manometry with solid state probes in different age groups.
Up to date no normal values for children exist for solid-state probes. In pediatrics and pediatric surgery therapies are often based on age specific normal values. Anorectal manometry is a widely used, low-risk, non-invasive diagnostic test. It has been used to further investigate incontinence, rule out Hirschsprung's disease, preoperatively and for monitoring of postoperative development of sphincter function in anorectal malformations and motility disorders.
For anorectal manometry either water-perfused or solid-state probes are available. Normal values for infants exist only for water-perfused systems. Solid-state systems are considerably more favourable.
Parameters measured in this study are anal resting pressure, anal canal length, symmetry, squeeze pressure, rectoanal inhibitory reflex in non-symptomatic children.

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Organizational Data

  •   DRKS00006154
  •   2014/05/21
  •   [---]*
  •   yes
  •   Approved
  •   12-101-0160, Ethikkommission an der Universität Regensburg
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Secondary IDs

  •   U1111-1157-0673 
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Health Condition or Problem studied

  •   Healthy Participants
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Interventions/Observational Groups

  •   Anomanometry with solid state probe is performed. Parameters measured in this study are anal resting pressure, anal canal length, symmetry, squeeze pressure, rectoanal inhibitory reflex in non-symptomatic children.
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Characteristics

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

Anorectal manometry testing in order to define normative data in different age groups

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Secondary Outcome

not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/04/08
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Months
  •   14   Years
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Additional Inclusion Criteria

children aged 0 - 14 years, consent of parents

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Exclusion Criteria

previous rectal surgery, previous abdominal surgery within last two month, existing problems with encopresis or constipation, chronic inflammatory bowel disease, Immunodificiency,history of prolonged bleeding, presence or privious fissures, acute gastoenteritis, acute pain or current pain therapy, consumption of medication having an effect on central nervous system (anti-epileptic drugs, methyphenidate), prokinetic agents or laxatives.

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Addresses

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    • Krankenhaus Barhmerzige Brüder, Klinik St. Hedwig
    • Steinmetzstraße 1-3
    • 93049  Regensburg
    • Germany
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    • ehemals Krankenhaus Barmherzige Brüder, Klinik St. Hedwig
    • Ms.  Dr.  Constanze  Kiese (vormals Hasselbeck) 
    • Steinmetzstraße 1-3
    • 93049  Regensburg
    • Germany
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    • ehemals Krankenhaus Barmherzige Brüder, Klinik St. Hedwig
    • Ms.  Dr.  Constanze  Kiese (vormals Hasselbeck) 
    • Steinmetzstraße 1-3
    • 93049  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik St. HedwigAbteilung für Kinderchirurgie
    • Mr.  Prof. Dr. med.  Bertram  Reingruber 
    • Steinmetzstr. 1-3
    • 93049  Regensburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/30
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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.