Trial document
DRKS00005691
Trial Description
Title
The "Proctological Symptom Scale" (PSS): Evaluation of a simple tool for the objective assessment of proctological complaints
Trial Acronym
[---]*
URL of the Trial
[---]*
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.
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.
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
Secondary IDs
- [---]*
Health Condition or Problem studied
- K64 - [---]*
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
Characteristics
- Non-interventional
- Observational study
- Other
- Open (masking not used)
- [---]*
- Other
- Other
- Parallel
- N/A
- N/A
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.
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.
Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Actual
- 2014/02/19
- 400
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
Additional Inclusion Criteria
Patients with proctological complaints as study group.
Patients and hospital staff without proctological complaints as control.
Exclusion Criteria
None
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-sponsorstart of 1:1-Block address contact primary-sponsor- +49-2381-6811401
- +49-2381-6811168
- mkraemer at barbaraklinik.de
- http://www.barbaraklinik.de
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-contactstart of 1:1-Block address contact scientific-contact- +49-2381-6811401
- +49-2381-6811168
- mkraemer at barbaraklinik.de
- http://www.barbaraklinik.de
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-contactstart of 1:1-Block address contact public-contact- +49-2381-6811401
- +49-2381-6811168
- mkraemer at barbaraklinik.de
- http://www.barbaraklinik.de
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- +49-(0)2381-6811401
- +49-(0)2381-6811168
- mkraemer at barbaraklinik.de
- http://www.barbaraklinik.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2014/08/01
Trial Publications, Results and other Documents
- DOI 10.1007/s00384-015-2160-7
- A simple tool to evaluate common disorders: validation of a “ proctological symptom scale”. M. Kraemer, D. Kara, M. Rzepisko, J. Sayfan. Int J Colorectal Dis 2015; 30:679-82