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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005691

Enrollment

400

Registered

2014-02-20

Start date

2014-02-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K64

Interventions

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 o

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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

Germany

Contacts

Public ContactMatthias Kraemer

Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm

mkraemer@barbaraklinik.de+49-2381-6811401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026