Back to resultsPeristomal Skin Complications and Quality of Life
Primary Purpose
Colorectal Cancer, Quality of Life, Stoma Ileostomy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION
Control
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- Ege University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
control
Arm Description
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.
The patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks.
Outcomes
Primary Outcome Measures
Rate of Peristomal skin complication change
It has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.
means of quality of life change
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04375930
Brief Title
Peristomal Skin Complications and Quality of Life
Official Title
The Effect of Standard-Based Care on Peristomal Skin Complications and Quality of Life in Ostomy Creation Patients With Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Quality of Life, Stoma Ileostomy, Stoma Colostomy, Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This two-group, single-blind, quasi-experimental study enrolled 68 patients with ostomy recruited to a university affiliated hospital.
Masking
Participant
Masking Description
The patients with an ostomy were blinded.
Allocation
Non-Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Active Comparator
Arm Description
The patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks.
Intervention Type
Other
Intervention Name(s)
STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION
Intervention Description
STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION: It is consist of skills, discharge, compilation and algorithm education.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
It consists of only skills and discharge education
Primary Outcome Measure Information:
Title
Rate of Peristomal skin complication change
Description
It has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.
Time Frame
0, 2nd, 6th and 12th weeks
Title
means of quality of life change
Description
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.
Time Frame
2nd, 6th and 12th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cahide Ayik
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University
City
İzmir
ZIP/Postal Code
35040
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Peristomal Skin Complications and Quality of Life
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