Trial document



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  DRKS00005691

Trial Description

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Title

The "Proctological Symptom Scale" (PSS): Evaluation of a simple tool for the objective assessment of proctological complaints

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Proctological complaints are common. Treatment modalities range from self-treatment with various ointments and suppositories to specialised procto-surgical interventions. Although no reliable data are available, there remains no doubt that proctological disease has a sizeable economic impact. Hence, a simple tool to identify useful and eliminate less useful therapeutic options seems desirable.

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Brief Summary in Scientific Language

Proctological symptomatology is of little complexity and therefore appears particularly suitable for simple comparative assessment. The idea of a symptom scale was first employed by Sayfan et al in studies focussing on the outcome of operative therapy of hemorrhoidal disease. The authors used visual analogue scales (VAS) to measure severity of five major anal symptoms (prolapse, bleeding, moisture, itching, pain). They were able to demonstrate a significant impact of the intervention on the VAS results. However, the scale was never tested on controls and the idea of expanding their use not pursued further.

Following a pilot phase of haphazard sampling of the original symptom scales as devised by Sayfan et al among a series of proctological patients we decided to exclude „prolapse“ as scale item since this item was least well understood by our patients. Furthermore, the item was almost never chosen and had only little impact but added avoidable complexity.
The „Proctological Symptom Scale“ (PSS) therefore comprises four items: anal pain, anal itching/irritation, anal moisture/soiling, anal bleeding. Patients are asked to mark their symptom severity on a 0 to 10 visual analogue scale (VAS) for each item separately.

In this study we are now testing this slightly modified version of the "Symptom Scale" to find out, whether the scale is a suitable instrument for the comparative assessment of proctological complaints.

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Organizational Data

  •   DRKS00005691
  •   2014/02/20
  •   [---]*
  •   yes
  •   Approved
  •   2014-097-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K64 -  [---]*
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Interventions/Observational Groups

  •   Patients who present with proctological complaints to our coloproctological clinic
  •   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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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/02/19
  •   400
  •   Monocenter 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

Patients with proctological complaints as study group.
Patients and hospital staff without proctological complaints as control.

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Exclusion Criteria

None

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Addresses

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    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung Allgemein- und Viszeralchirurgie, Koloproktologie
    • Mr.  Priv-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/08/01
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Trial Publications, Results and other Documents

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