Trial document




drksid header

  DRKS00005691

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

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
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K64 -  [---]*
end of 1:N-Block indications
start of 1:N-Block interventions

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
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/02/19
  •   400
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

None

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Abteilung Allgemein- und Viszeralchirurgie, Koloproktologie
    • Mr.  Priv-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/08/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.