Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000359

Trial Description

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Title

Hospital-based, Prospective, Multicentre
Surveillance to determine the incidence of
intussusception in children aged < 15 Years in
Germany

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to evaluate the real incidence of intussusception in children below 15 years of age in Germany
by means of a hospital based prospective multi-centre surveillance. Data on all cases of intussusception in Germany in
2006 and 2007 were collected from the ESPED central register for rare pediatric diseases and the incidence of intussusception
was determined. This procedure bears the risk to under estimate the real incidence. Therefore a random sample of 31 hospitals
was re-assessed for their cases of intussusception. Based on this evaluation the under reporting quote was estimated and
with information the corrected incidence was calculated. A Maximum-Likelihood-Estimator was used to determine the real
incidence for intussusception.

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Brief Summary in Scientific Language

Background
A new vaccination against Rotavirus gastroenteritis (RV) has been introduced in Germany 2006. Since in 1997 the first RV vaccine has been withdrawn due to an association with an increase in intussusception incidence, an accurate estimation of the incidence of IS is important for post-licensure surveillance.
Methods
IS-Data were obtained from the ESPED collaborations? central register where all cases of intussusception in Germany (n=1200) for the years 2006 and 2007 are collected. In order to obtain an unbiased estimate of the incidence it is necessary to assess the population under risk these cases originated from, and the proportion of real cases not reported to the registry (underreporting). In order to assess underreporting a random sample of 31 hospitals was reviewed by an outside reviewer. The estimation of incidence was done using a single Maximum-Likelihood estimator using the data from both the registry and the sample.
Results
The uncorrected observed incidence was calculated to be 26.6/100,000 child-years for children <1 year old, 23.8 for those <2 years old, and 5.2 among those of age <15 years. Review revealed a mean reporting quota of about41% and the ML approach yielded an incidence of 51.5/100,000 child-years (95%CI [41.7;61.1]) for children below <2 years of age.
Conclusions
While substantial under-reporting led to very conservative estimates of the IS incidence, the approach described here allows an accurate estimation of IS incidence including corresponding confidence bands. Therefore ML estimation is a straightforward instrument to derive stable, unbiased estimates in epidemiological studies with incomplete data.

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Organizational Data

  •   DRKS00000359
  •   2010/09/29
  •   [---]*
  •   yes
  •   Approved
  •   71/2008, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   K56.1 -  Intussusception
  •   K38.8 -  Other specified diseases of appendix
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Interventions/Observational Groups

  • [---]*
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Characteristics

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

To prospectively estimate the annual incidence of IS in children aged < 2 years through paediatric hospital based surveillance in Germany.

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Secondary Outcome

To prospectively estimate the annual incidence of IS in children aged < 15 years through paediatric hospital based surveillance in Germany.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2006/02/01
  •   1593
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

To be a male or a female child < 15 years of age at the time of enrolment into the study (patient becomes ineligible on the day of 15th birthday)
Subject fulfilling Brighton Collaboration's Group Criteria for intussusception diagnosis.
Intussusception diagnosis occurring during the two year study period.

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Exclusion Criteria

Diagnosis of intussusception based solely on clinical signs and symptoms.
Means for diagnosis of intussusception cannot be determined.

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Addresses

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    • Ruhr-Universität Bochum Abteilung für Medizinische Informatik, Biometrie und Epidemiologie
    • Mr.  Prof. Dr.  Hans J.  Trampisch 
    • Overbergstr. 17
    • 44801  Bochum
    • Germany
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    • Ruhr-Universtität Bochum Abteilung für Medizinische Informatik, Biometrie und Epidemiologie
    • Mr.  Prof. Dr.  Trampisch  Hans J. 
    • Overbergstrasse 17
    • 44801  Bochum
    • Germany
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    • Ruhr-Universität Bochum Abteilung für Medizinische Informatik, Biometrie und Epidemiologie
    • Mr.  Prof. Dr.  Hans J.   Trampisch 
    • Overbergstrasse 17
    • 44801  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Sanofi Pasteur MSD
    • 8 rue Jonas Salk
    • 69367  Lyon cedex 07
    • France
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    • Glaxosmithkline Biologicals
    • 89 rue de l'Institut
    • 1330  Rixensart
    • Belgium
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    • Ruhr-Universität Bochum Abteilung für Medizinische Informatik, Biometrie und Epidemiologie
    • Mr.  Prof. Dr.  Hans J.   Trampisch 
    • Overbergstr. 17
    • 44801  Bochum
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/08/31
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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.