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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: |
DRKS00005691 |
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Date of registration:
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20/02/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The "Proctological Symptom Scale" (PSS): Evaluation of a simple tool for the objective assessment of proctological complaints
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Scientific title:
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The "Proctological Symptom Scale" (PSS): Evaluation of a simple tool for the objective assessment of proctological complaints |
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Date of first enrolment:
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19/02/2014 |
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Target sample size:
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400 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00005691 |
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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: other
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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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+49-2381-6811401 |
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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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+49-2381-6811401 |
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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 with proctological complaints as study group.
Patients and hospital staff without proctological complaints as control.
Exclusion criteria: None
Age minimum:
None
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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K64
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Haemorrhoids and perianal venous thrombosis
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Intervention(s)
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Group 1: Patients who present with proctological complaints to our coloproctological clinic
Group 2: Patients who present to our department for non-proctological complaints (e.g. for cholecystectomy or hernia repair) and hospital staff without proctological complaints willing to fill in the PSS
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Primary Outcome(s)
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Age- and sex-stratified comparison of scale values of the non-proctological cohort and the proctological cohort at first presentation. Within each cohort the relative impact of each scale item for the overall results will be analysed separately.
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Secondary Outcome(s)
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1. Stability of scale values over time without intervention. This will be assessed by comparison of individual scale values at first presentation and those at the re-appointment for the first Barron ligation.
2. Effects of consecutive interventions (Barron ligations) on scale values by separate comparative analysis of each session (i.e. first ligature vs second ligature etc.)
3. Sensitivity of the PSS to detect therapeutic failure will be assessed by additional chart review of cases whose overall scale value persisted or deteriorated following two or more Barron ligations.
4. In order to establish whether the PSS could in part or entirely be replaced by the more established incontinence or constipation-scores, the three instruments will be compared in one hundred consecutive patients who are left unguided when filling in the three tools. The measured values will be compared by correlation of low (lower third), medium (medium third), high (upper third) results for each score in each individual patient. Rates of completeness are to be separately analyzed for each score.
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Source(s) of Monetary Support
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Abteilung Allgemein- und Viszeralchirurgie, Koloproktologie
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Ethics review
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Status: Approved
Approval date: 18/02/2014
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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