Peristomal Skin Complications and Quality of Life

June 23, 2022 updated by: Cahide AYİK, Dokuz Eylul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35040
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
The patient will be trained with STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION. The patient will be follow up at 2nd, 6th and 12th weeks.
Other: STANDARD 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.
Active Comparator: control
The patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks.
Other: Control
It consists of only skills and discharge education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Peristomal skin complication change
Time Frame: 0, 2nd, 6th and 12th weeks
It has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.
0, 2nd, 6th and 12th weeks
means of quality of life change
Time Frame: 2nd, 6th and 12th weeks
It 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.
2nd, 6th and 12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Principal Investigator: Cahide Ayik, Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3491-GOA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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