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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00005612 |
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Date of registration:
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07/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Is obstructed defecation the cause for diverticular disease? Investigation of clinical and proctological findings in patients with diverticular disease.
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Scientific title:
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Is obstructed defecation the cause for diverticular disease? Investigation of clinical and proctological findings in patients with diverticular disease. |
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Date of first enrolment:
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13/01/2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00005612 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Matthias
Kraemer |
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Address:
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Am Heessener Wald 1
59073
Hamm
Germany |
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Telephone:
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+49-2381-6811400 |
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Email:
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mkraemer@barbaraklinik.de |
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Affiliation:
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Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm |
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Name:
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Matthias
Kraemer |
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Address:
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Am Heessener Wald 1
59073
Hamm
Germany |
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Telephone:
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+49-2381-6811400 |
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Email:
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mkraemer@barbaraklinik.de |
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Affiliation:
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Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm |
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Key inclusion & exclusion criteria
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Inclusion criteria: Disease criteria:
Confirmed diverticulosis of the colon irrespective of whether the presentation is due to acute inflammation or not.
The diagnosis of diverticulosis of the colon is based on colonic contrast enema, CT, colonoscopy. The diagnosis is considered as confirmed if diverticulosis is poistively detected by any one of the mentioned investigations, i.e. patients do not have to undergo all the investigations.
In cases of diverticulitis the disease activity is classified according to Hinchey and to Hansen/Stock.
Patient criteria:
- informed consent to undergo an extensive coloproctological workup
- age 18 and older
Exclusion criteria: - unableness to give informed consent to the study
- age younger than 18 years
- poor general or health condition and/or old age prohibiting exposure to a thorough coloproctological workup
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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K57
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Diverticular disease of intestine
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Intervention(s)
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Group 1: The study focusses on the rate of manifestations of obstructed defecation in patients with verified diverticulosis of the colon, irrespective of whether the manifestation is acute inflammatory or not. The following investigations serve as positive confirmation of colonic diverticulosis: colonic contrast-enema, CT, colonoscopy.
Manifestations of obstructed defecation are recorded by a detailed coloproctological history and examination. The investigations also include a functional proctoscopy and a balloon-expulsion-test. If the findings justify further investigations an additional radiological examination is offered (defaecography).
The following findings are considererd as contributing to obstructed defecation: internal or external rectal prolapse, rectal mucosal prolapse, descending perineum, rectocele, obstructing sigmoidocele ("cul-de-sac").
Evidence of proctological complaints and rectal evacuation disorders are also recorded.
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Primary Outcome(s)
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Rate of obstructed-defecation associated manifestations in history, symptomatology, and morphology in patients with proven diverticulosis of the colon.
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Secondary Outcome(s)
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Rate of patients who have a previous diagnosis of "irritable bowel syndrom", "funtional dyspepsia" or similar functional disorders among patients with proven divertcular disease of the colon.
Correlation of subjektive symptoms of obstruction with objective morphology in patients wiith confirmed features of obstructed defecation.
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Source(s) of Monetary Support
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Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
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Ethics review
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Status: Approved
Approval date: 16/12/2013
Contact:
ethik-kommission@aekwl.de
Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
+49-251-9292460
ethik-kommission@aekwl.de
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