Trial document




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  DRKS00007871

Trial Description

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Title

Registry for proctocolectomy in Ulcerative colitis

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Trial Acronym

ReProCu

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Study objective is to establish a registry in Germany that collects data of ulcerative colitis aetiopathology, drug therapy, course of procotcolectomy and state of health after conducted proctocolectomy. In particular, data of the disease such as severity, extent, medication, diagnostic findings, surgical procedures or complications are to be collected on a case report form. This documentation is to be performed prior to surgery, shortly after surgery and in the context of after-care.

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Brief Summary in Scientific Language

Study objective is to investigate, prospectively and multicentric in Germany, the influence of preoperative course of disease and therapy in ulcerative colitis on the outcome of protocolectomies that have been becoming necessary in the course of disease with particular focus on the influence of premedication.

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Organizational Data

  •   DRKS00007871
  •   2015/04/07
  •   [---]*
  •   yes
  •   Approved
  •   14-115, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1167-9233 
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Health Condition or Problem studied

  •   K51 -  Ulcerative colitis
  •   proctocolectomy
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Interventions/Observational Groups

  •   Ulcerative colitis patients with an indication for proctocolectomy are to be documented before surgery, shortly after surgery and during the follow-up regarding data of their disease, such as severity, extent, medication, diagnostic findings, surgical procedure and complications documented. In addition, these patients are asked before surgery and during the follow-up for their quality of life with the questionnaire "GIQLI" (Gastrointestinal Quality of Life).
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Characteristics

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

Severity of the occurrence of peri- and postoperative complications with particular focus on premedication.

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Secondary Outcome

Pouch functionality,
Quality of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/05/27
  •   400
  •   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

1. Ulcerative colitis patients with an indication for proctocolectomy, 2. signed informed consent, 3. no age limit

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Exclusion Criteria

1. Crohn´s disease, 2. missing informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für ChirurgieUniversitätsklinikum Schleswig-Holstein, Campus Lübeck
    • Mr.  Dr. med.   Tilman  Laubert 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Chirurgie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
    • Mr.  PD Dr. med.  Tilman  Laubert 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Chirurgie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
    • Mr.  PD Dr. med.  Tilman  Laubert 
    • Ratezburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Kompetenznetz DarmerkrankungenGerman IBD Study Group (bisher; aktuell wird Studie nicht mehr vom der GISG unterstützt und es obliegt dem Studienleiter, eine neue Finanzierungsquelle anzugeben oder ggf. die Studie als "gestoppt" einzustufen)
    • Hopfenstraße 60
    • 24103 Kiel 
    • Germany
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    •   [---]*
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    •   [---]*
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Status

  •   Recruiting suspended on temporary hold
  •   [---]*
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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.