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

NCT07369219 | Active Not Recruiting

• 1 other identifier: Approval number 2025-03/147
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Home Care; Stoma; Enhanced Recovery

Outcome Measures

Primary Outcomes (4)

• KATZ Activities of Daily Living (ADL) Scale

  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

  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

  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

  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 Outcomes (3)

• Day of hospital stay

  Up to 30 days after the patient's hospitalization date.

• complications

  Up to postoperative day 30

• Readmisson

  Within 30 days after discharge

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

intervention group

EXPERIMENTAL

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

Interventions

Educational intervention BEHAVIORAL

A structured discharge education program supported with a home-care booklet and scheduled telephone follow-up at postoperative days 3, 7, 10, and 30.

intervention group

Standard maintenance therapy OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Acıbadem Maslak Hospital

Istanbul, Istanbul, 34050, Turkey (Türkiye)

Location

Related Publications (5)

• Storm M, Morken IM, Austin RC, Nordfonn O, Wathne HB, Urstad KH, Karlsen B, Dalen I, Gjeilo KH, Richardson A, Elwyn G, Bru E, Soreide JA, Korner H, Mo R, Stromberg A, Luras H, Husebo AML. Evaluation of the nurse-assisted eHealth intervention 'eHealth@Hospital-2-Home' on self-care by patients with heart failure and colorectal cancer post-hospital discharge: protocol for a randomised controlled trial. BMC Health Serv Res. 2024 Jan 4;24(1):18. doi: 10.1186/s12913-023-10508-5.

  PMID: 38178097 RESULT

• Lin L, Fang Y, Wei Y, Huang F, Zheng J, Xiao H. The effects of a nurse-led discharge planning on the health outcomes of colorectal cancer patients with stomas: A randomized controlled trial. Int J Nurs Stud. 2024 Jul;155:104769. doi: 10.1016/j.ijnurstu.2024.104769. Epub 2024 Apr 5.

  PMID: 38676992 RESULT

• van Rooijen S, Carli F, Dalton S, Thomas G, Bojesen R, Le Guen M, Barizien N, Awasthi R, Minnella E, Beijer S, Martinez-Palli G, van Lieshout R, Gogenur I, Feo C, Johansen C, Scheede-Bergdahl C, Roumen R, Schep G, Slooter G. Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation. BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

  PMID: 30670009 RESULT

• Li MZ, Wu WH, Li L, Zhou XF, Zhu HL, Li JF, He YL. Is ERAS effective and safe in laparoscopic gastrectomy for gastric carcinoma? A meta-analysis. World J Surg Oncol. 2018 Jan 26;16(1):17. doi: 10.1186/s12957-018-1309-6.

  PMID: 29373978 RESULT

• Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.

  PMID: 15896435 RESULT

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: January 27, 2026
• Study Start: May 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)