Clinical trial NCT05958433: Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients
Official title: Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized, controlled trial aiming to assess the effects of preoperative education using stoma appliance on stoma self-care, quality of life, anxiety, and depression levels in colorectal cancer patients with a stoma.

Detailed description: Colorectal cancer is third cancer worldwide after breast and lung cancer accounting for 10% of all cancer cases and 9.4% of cancer deaths. Over 2.2 million new colorectal cancer cases and 1.8 million deaths have been estimated to occur in 2020. In Egypt, it is the seventh cancer, accounting for 3.9% of all cancers, with about 5,000 new cases annually.

Colorectal resections are often associated with temporary or permanent stoma formations. In the United Kingdom it is estimated that more than 20,000 new stomas are created each year, 11,800 of them were colostomies. About one-half of the stoma was permanent. The formation of a stoma is associated with psychologic morbidity, which can be reduced with preoperative and postoperative patient education and psychologic support.

Living with a stoma is a challenging situation for various reasons including uncontrolled gas passage through it, diarrhea, odor, and leakage around the stoma or appliance. It would take several months for the patients to adjust to this difficult time. At that point, the patient's Quality of life becomes essential for the remaining time.

Ostomy formation is one of the therapeutic procedures performed to manage bowel dysfunction due to various reasons; however, it affects quality of life of patients. World health organization defines QOL as an individual's perspective of his/her health status concerning a few aspects- physical, psychological, economic, social, and environmental.

A stoma influences the physical, mental, emotional, and social life of the patient significantly. A good quality of life is essential to achieve a comprehensive approach to treating patients. A study done in China to assess stoma related quality of life using a stoma self-care agency scale and health hope index showed that patients had difficulties in work and social institutions. Additional concerns pointed out were sexuality, body image and the stoma itself. A long-term effect on the quality of life of members of the United Ostomy Association of America after 5 years of ostomy surgery was assessed using a questionnaire. Their report has shown that patients feel better as they live longer with the stoma. Research done on Iranian by ostomy society has shown that factors such as the type of ostomy, the underlying disease that had led to the stoma formation, depression after ostomy, dissatisfaction with sexual activities, a problem with the location of ostomy and change in clothing style affected the Quality of Life.

Ostomies can lead to intensified distress and suffering in patients because of skin irritation (76%), pouch leakage (62%), offensive odor (59%), reduction in pleasurable activities (54%), and depression/anxiety (53%). In such circumstances, it is worthwhile to assess the quality of life in the evaluation of the outcomes of various therapeutic procedures along with their final impact on patients' lives. Quality of care and training provided to patients can be associated with their subsequent quality of life. The main aim of this study is to assess the effects of preoperative education on stoma self-care, quality of life, Anxiety, and depression levels in colorectal cancer patients with a stoma.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective operable colorectal resections that would require the formation of a temporary or permanent stoma.
* Patients who were likely to be self-sufficient in managing their stoma pouching system after surgery.

Exclusion Criteria:

1. Those who undergo emergency surgery
2. Disoriented patients who cannot cooperate.
3. Patients with psychiatric disease.

Primary outcomes:
measure: duration of hospital stay
timeFrame: 1 year
Secondary outcomes:
measure: Assess anxiety and depression
timeFrame: 9 monthes
measure: assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma
timeFrame: 11 months
Other outcomes:
Locations:
Study officials:
affiliation: Prof. Biostatistics & Cancer Epidemiology National Cancer Institute, Cairo University
name: Nelly AliEldien, proffesor
role: STUDY_CHAIR
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