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NCT Number: NCT04375930

Peristomal Skin Complications and Quality of Life

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Complication Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Rectal Diseases Stoma Colostomy Stoma Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, 35040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Other

It consists of only skills and discharge education

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 6, 2020
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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