Peristomal Skin Complications and Quality of Life

Not Applicable

Completed

• Conditions: Stoma Ileostomy; Quality of Life; Stoma Colostomy; Complication; Colorectal Cancer
• Interventions: Other: STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION; Other: Control

• Registration Number: NCT04375930
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2019-01-18
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-06
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION	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.
control	Control	The patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks.

Primary Outcome Measures

Name	Time	Method
Rate of Peristomal skin complication change	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.
means of quality of life change	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.

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Turkey