Effect of a Nursing Care Intervention on Outcomes of Stoma Patients Within an Enhanced Recovery Framework

January 22, 2026 updated by: Özlem Kıvanç, Bahçeşehir University

Investigating the Effect of a Care Intervention Implemented in Stoma Patients Receiving Care Based on Enhanced Recovery Propositions on Patient Outcomes and Home Care Management: A Mixed Methods Study

Colorectal cancer is one of the most common cancers in the world and affects a large number of people every year. Surgical intervention and neoadjuvant treatment are mostly preferred for treatment, and temporary or permanent stoma is often opened. Complications that are difficult to manage may arise due to the treatment itself, the disease or the stoma. Complications that are difficult to manage carry a high risk of re-hospitalization. Patients receive limited support during the transition from hospital to home and at home. Patients and their relatives are often alone in home care management until the routine check-up process. Especially patients who are not well prepared for discharge and inadequate in stoma management may not know how to apply care practices during this period at home and the situations they should pay attention to in case of complications. Conditions that can be managed well in the hospital may get out of control when the patient goes home and may cause unplanned re-admissions to the hospital if there is not enough follow-up. Inadequate patient follow-up after surgery may cause patients to be anxious and therefore may cause re-hospitalization due to the inability to manage the home care process in a controlled manner.

Although it is known that the duration of hospital stay is shortened with advanced improvement suggestions, different results are remarkable in studies on hospital readmissions, reoperations, developing complications and survival. Since the care needs of patients after surgical intervention vary, there is a need for individualized and evidence-supported suggestions. Currently, advanced improvement suggestions do not include the answer to the question and roadmap of how patients will be followed at home after discharge. The surgical journey should be followed with comprehensive care application steps that are a continuation of evidence-based practices that start from the moment the patient is admitted to the hospital, making them feel that they are not alone during the recovery process they will spend at home after being discharged. The provision of home care management is important for the continuity of the recovery process. Although there are various application models used in the literature for the purpose of preparing and following up on the discharge process, no study has been found that focuses on comprehensive discharge preparation and home care management of stoma patients receiving care in line with advanced recovery recommendations. In this sense, it is believed that the study will be a fundamental study in terms of developing a fourth phase, post-discharge home care management, which is the continuation of the pre-, intra- and post-operative process as included in advanced recovery guidelines and a gap in the literature.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34050
        • Acıbadem Maslak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Agree to participate in the study

    • Be 18 years of age or older
    • Be able to communicate in Turkish
    • Have no visual or hearing impairment
    • Elective colorectal surgery in line with advanced treatment recommendations Having a stoma opened for the first time due to colorectal cancer

Exclusion Criteria:

  • patients who did not meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Routine hospital discharge education, usual stoma care follow-up, and standard postoperative monitoring without the additional structured education booklet or planned telephone follow-up.
Other: Standard maintenance therapy
Routine postoperative stoma care and standard hospital discharge education provided according to institutional protocols. Usual care includes routine monitoring of the stoma site, general postoperative recovery assessment, complication screening, and standard follow-up visits without the structured education booklet or scheduled telephone follow-up program.
Experimental: intervention group
A structured discharge education program supported with a home-care booklet and scheduled telephone follow-up at postoperative days 3, 7, 10, and 30.
Behavioral: Educational intervention
A structured discharge education program supported with a home-care booklet and scheduled telephone follow-up at postoperative days 3, 7, 10, and 30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KATZ Activities of Daily Living (ADL) Scale
Time Frame: Baseline (pre-discharge) and postoperative day 30
If the individual can do their ADL independently, they are given 3 points, if they are partially assisted, they are given 2 points, if they cannot do it at all, they are given 1 point and the evaluation is made accordingly. In the evaluation made according to this scale, 0-6 points are evaluated as dependent, 7-12 points as partially dependent, and 13-18 points as independent. Accordingly, as the score obtained from the scale increases, dependency decreases.
Baseline (pre-discharge) and postoperative day 30
EORTC QLQ-C30 Quality of Life Scale
Time Frame: Baseline (pre-discharge) and postoperative day 30
The lowest total score that patients can get from the functional score, symptom score and general health score is 0, and the highest score is 100. A high score from the functional scales indicates a healthy functional level, a high score from the general health status scale indicates a high quality of life, and a high score from the symptom scale indicates that symptoms are experienced intensely and the level of the problem is high.
Baseline (pre-discharge) and postoperative day 30
Stoma-Self-Efficacy Scale
Time Frame: Baseline (pre-discharge) and postoperative day 30
The total score of the scale ranges from 22 to 110, with higher scores indicating increased self-efficacy levels of patients.
Baseline (pre-discharge) and postoperative day 30
Readiness for Discharge Scale
Time Frame: Up to 30 days after the patient's hospitalization date.
If the scale dimensions score was ≥7, the patient was considered ready for discharge, and if it was <7, it was considered not ready.
Up to 30 days after the patient's hospitalization date.

Secondary Outcome Measures

Outcome Measure
Time Frame
Day of hospital stay
Time Frame: Up to 30 days after the patient's hospitalization date.
Up to 30 days after the patient's hospitalization date.
complications
Time Frame: Up to postoperative day 30
Up to postoperative day 30
Readmisson
Time Frame: Within 30 days after discharge
Within 30 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 16, 2025

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Approval number 2025-03/147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is patient specific, therefore, other data will not be shared except for the research results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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