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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: |
DRKS00005662 |
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Date of registration:
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21/01/2014 |
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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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Secondary structural Changes of the Rectal Wall in Rectal Prolapse: a Functional Pathological Study on Resection Specimens with Correlation of Clinical Findings
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Scientific title:
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Secondary structural Changes of the Rectal Wall in Rectal Prolapse: a Functional Pathological Study on Resection Specimens with Correlation of Clinical Findings |
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Date of first enrolment:
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23/01/2014 |
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Target sample size:
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50 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00005662 |
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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-(0)2381-6811401 |
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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-(0)2381-6811401 |
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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: Patients who are diagnosed with obstructed defaecation and rectocele/rectal prolapse following the routine preoperative therapeutic and diagnostic protocol and who are indicated for the STARR-procedure.
Exclusion criteria: previous rectal operation during the last 12 months
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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K59.0
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K62.3
K59.0
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K62.3
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Constipation
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Rectal prolapse
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Intervention(s)
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Group 1: Patients who are diagnosed with obstructed defaecation and rectocele/rectal prolapse following the routine preoperative therapeutic and diagnostic protocol and who are indicated for the STARR-procedure. For this study STARR resection specimens are to be pathologically examined for macro- and micromorphological changes which are then correlated to clinical findings. This is done by a study adapted recording of the clinical data and by a detailed histopathological examination of the specimens according to functional and neuropthological criteria.
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Primary Outcome(s)
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- rate and extent of histopathologically ascertainable structural impairement and defects in STARR-specimens
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Secondary Outcome(s)
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- correlation of documented structural damage with clinical findings, patient age, and sex
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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: 13/01/2014
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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