SCOPE - Single-Point Classification Observational Peristomal Evaluation

A Single-Time-Point, Observational Study to Evaluate Interrater Reliability of SACS 2.0 for the Assessment of Peristomal Skin Health in Ostomates

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06614491

Enrollment

605

Registered

2024-09-26

Start date

2024-12-06

Completion date

2025-12-31

Last updated

2026-01-08

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

Conditions

Colostomy, Ileostomy, Urostomy

Brief summary

Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.

Detailed description

The purpose of this study is to create an ostomy dataset and collect stoma photos to enable SACS 2.0 evaluation of images digitally versus an in-person ostomy skin assessment.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with ileostomy, colostomy or urostomy * Age ≥ 18 years of age * Able and willing to provide informed consent

Exclusion criteria

* Enterocutaneous fistulae * Patients with two or more ostomies

Design outcomes

Primary

Measure	Time frame	Description
Reliability of SACS assessment	Baseline	The equivalence of weighted Kappa concordance between SACS assessment via in-person skin assessment by an ostomy care nurse and SACS assessment via examining the skin via photo by a study nurse coordinator

Secondary

Measure	Time frame	Description
Ostomy dataset	Baseline	Frequency of peristomal skin health classification scores in 600 consecutive ostomates

Countries

Brazil, Colombia

Outcome results