Trial document



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  DRKS00006132

Trial Description

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Title

Health related quality of life after operative or conservative treatment of recurrent diverticular disease of the sigmoid colon: a monocentric cohort study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients who were treated for chronic diverticular disease at the Schön Klinik Neustadt will be surveyed by questionnaire. The aim of this study is to examine the effect of the treatment on the patients’ health related quality of life.

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Brief Summary in Scientific Language

Diverticular disease is the inflammation of diverticula on the grounds of local obstruction caused by compressed faeces or indigestible food compounds and predisposing factors. In western industrialised nations, diverticular disease is common and its prevalence increases with age. Diverticula can be found in 70% of 80-year-olds but in only about 5% of 40-year-olds, those diverticula are mostly asymptomatic. In this study only patients with chronic-recurrent Diverticular disease will be included (equivalent to Hansen Stock Stadium III). Currently there is no German guideline for the treatment of diverticular disease. The guidelines of the Scientific Committee of the European Association for Endoscopic Surgery Task Force and the American Society of Colon and Rectal Surgeons suggest a surgical approach after the second episode of diverticular disease. Few Studies have been conducted aiming to investigate the effect of the treatment on the quality of life. Patients who have received treatment for chronic-recurrent diverticular disease as the major diagnosis between 01.01.2010 and 31.12.2011 at the Schön Klinik Neustadt will be included in this study. Primary aim of the study is the comparison of the health related quality of life after operative or conservative treatment in patients with chronic-recurrent diverticular disease

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006132
  •   2014/05/23
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  •   yes
  •   Approved
  •   13-165, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   K57.22 -  [generalization K57.2: Diverticular disease of large intestine with perforation and abscess]
  •   K57.23 -  [generalization K57.2: Diverticular disease of large intestine with perforation and abscess]
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Interventions/Observational Groups

  •   Patient survey by questionnaire. All patients will be included who were diagnosed with chronic recurrent diverticular disease and who received inpatient treatment at Schön Klinik Neustadt between Jan 01, 2010 and Dec 31, 2011.
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Characteristics

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

health related quality of life measured by the Gastro-intestinal Quality of Life Index (GIQLI) 3-4 years after inpatient treatment

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Secondary Outcome

- frequency of recurrences
- time to recurrence
- late complications
- quality of life after open surgical procedure
- quality of life after laparoscopic surgical procedure
- frequency of recurrences in men
- frequency of recurrences women
- proportion of patients with abdominal pain

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/06/04
  •   106
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Chronic recurrent diverticular disease
- Inpatient treatmet at Schön Klinik Neustadt between Jan 01, 2010 and Dec 31, 2011.

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Exclusion Criteria

none

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Addresses

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    • Schön Klinik NeustadtKlinik für Chirurgie und Unfallchirurgie
    • Am Kiebitzberg 10
    • 23730  Neustadt in Holstein
    • Germany
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    •   04561 54-45 71 00
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    • Klinik für Chirurgie und UnfallchirurgieSchön Klinik Neustadt
    • Mr.  Prof. Dr. med Med. dr.  Hendrik  Schimmelpenning 
    • Am Kiebitzberg 10
    • 23730  Neustadt in Holstein
    • Germany
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    • Klinik für Chirurgie und UnfallchirurgieSchön Klinik Neustadt
    • Mr.  Prof. Dr. med Med. dr.  Hendrik  Schimmelpenning 
    • Am Kiebitzberg 10
    • 23730  Neustadt in Holstein
    • Germany
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Sources of Monetary or Material Support

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    • Schön Klinik Neustadt, Klinik für Chirurgie und Unfallchirurgie
    • Kiebitzweg 10
    • 23730  Neustadt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/09/25
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Trial Publications, Results and other Documents

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