CP384 - Ostomy Care (OC) PRO Panel Plan

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07589907

Acronym

384 PRO Panel

Enrollment

1000

Registered

2026-05-15

Start date

2026-06-01

Completion date

2032-10-31

Last updated

2026-05-15

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

Conditions

Ileostomy - Stoma, Ostomy, Urostomy

Brief summary

The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects living with a stoma (ileostomy, colostomy or urostomy).

Detailed description

The objective of the registry is to allow for insights into the needs of people with intimate healthcare needs from the perspective and experience of the user of ostomy products. The registry will provide valuable information from the participants' perspective on several issues including but not limited to product use and satisfaction, frequency of leakage and peristomal skin complications (PSC), healthcare use, and Quality-of-Life (QoL) both general and stoma related. The registry will allow for a more user-centric approach, when listening and responding to the needs and challenges of people living with a stoma.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or above * full legal capacity * willing and able to complete online questionnaires * have either an ileostomy, a colostomy, or a urostomy

Exclusion criteria

* Cannot have a scheduled stoma reversal surgery * Cannot have more than one stoma

Design outcomes

Primary

Measure	Time frame	Description
Number of OC products used by subjects.	5 years	Characterization of a cohort of ostomy care (OC) users at point-of-entry to the registry including e.g., but not limited to OC product consumption, user-patterns, and use of supporting products.
The number of leakage events	5 years	Frequency and consequences of leakages and Peristomal Skin Complications (PSC).
The Mental well-being index (WHO-5)	5 years	Quality-of-life (QoL) using the Mental well-being index (WHO-5). The subject has 5 questions asked, with 6 different responses available: "All of the time", "Most of the time", "More than half the time", "less than half the time", "some of the time", and "at no time". The choice of "all of the time" equates to a better well-being than a response of "at no time".

Contacts

CONTACTCarri Browne. Clinical Project Manager, BS

dkcarr@coloplast.com6123235772

CONTACTAnn-Sophie luel-Brockdorff, Sr. Clinical Strategy Project Manager, PhD

dkasib@coloplast.com+45 49112078

STUDY_DIRECTORAnn-Sophie Luel-Brockdorff, PhD

Coloplast A/S

Outcome results