Peristomal Skin Complications and Quality of Life

NCT04375930 | Completed DMC

• 1 other identifier: 3491-GOA
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  0, 2nd, 6th and 12th weeks

• 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.

  2nd, 6th and 12th weeks

Study Arms (2)

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

control

ACTIVE COMPARATOR

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

Other: Control

Interventions

STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION OTHER

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

Experimental

Control OTHER

It consists of only skills and discharge education

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Ege University

Izmir, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Cahide Ayik

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients with an ostomy were blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

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

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: May 6, 2020
• Study Start: January 18, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

TU (1)