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Peristomal Skin Complications and Quality of Life

D

Dokuz Eylül University (DEU)

Status

Completed

Conditions

Stoma Colostomy
Complication
Quality of Life
Stoma Ileostomy
Colorectal Cancer

Treatments

Other: Control
Other: STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION

Study type

Interventional

Funder types

Other

Identifiers

NCT04375930
3491-GOA

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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