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Peristomal Skin Complications and Quality of Life

The Effect of Standard-Based Care on Peristomal Skin Complications and Quality of Life in Ostomy Creation Patients With Colorectal Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04375930
Enrollment
68
Registered
2020-05-06
Start date
2019-01-18
Completion date
2020-06-01
Last updated
2022-06-28

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

Conditions

Colorectal Cancer, Complication, Quality of Life, Stoma Colostomy, Stoma Ileostomy

Brief summary

This study is a single blind semi-experimental study. Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery. H1: Standard stoma care which is established evidence-based guides and complication algorithm, reduces peristomal skin complications in patients with colorectal cancer and an ostomy. H2: Standard stoma care which is established evidence-based guides and complication algorithm, increases the quality of life in patients with colorectal cancer and an ostomy.

Detailed description

In order to ensure blindness in the study design, patients were not informed about which group they belonged to. Patient with ostomy in the study group were trained in accordance with the Standard Stoma Care. Patient with ostomy in the control group only skill and discharge training has been provided in accordance with the hospital procedure. All patients were followed up at 2, 6, and 12 weeks. Peristomal complications were evaluated by the researcher with the Peristomal Skin Tool at the 2nd, 6th and 12th weeks. The patients were asked to fill the Stoma Quality of Life Scale in the 2nd, 6th and 12th weeks.

Interventions

OTHERSTANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION

STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION: It is consist of skills, discharge, compilation and algorithm education.

OTHERControl

It consists of only skills and discharge education

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

The patients with an ostomy were blinded.

Intervention model description

This two-group, single-blind, quasi-experimental study enrolled 68 patients with ostomy recruited to a university affiliated hospital.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* undergoing colorectal surgery, * permanent or temporary ileostomy or colostomy * end or loop ileostomy or colostomy

Exclusion criteria

* individuals who have previously had stoma surgery, * having two or more stoma, * individuals with crohn's disease * individuals who do not want to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Rate of Peristomal skin complication change0, 2nd, 6th and 12th weeksIt has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.
means of quality of life change2nd, 6th and 12th weeksIt has been assessed with stoma Quality of Life Scale. The Scale range: 0-100. Higher scores for each item indicate that the quality of life increased.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026