Peristomal Skin Complications and Quality of Life

NCT ID: NCT04375930

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2020-06-01

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Quality of Life Stoma Ileostomy Stoma Colostomy Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

SINGLE

Participants
The patients with an ostomy were blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION

Intervention Type OTHER

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

control

The patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

It consists of only skills and discharge education

Interventions

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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.

Intervention Type OTHER

Control

It consists of only skills and discharge education

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Cahide AYİK

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cahide Ayik

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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3491-GOA

Identifier Type: -

Identifier Source: org_study_id

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