Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients
Primary Purpose
Rehabilitation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation with stoma appliance
Sponsored by
About this trial
This is an interventional health services research trial for Rehabilitation
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: Those who undergo emergency surgery Disoriented patients who cannot cooperate. Patients with psychiatric disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard postoperative education.
preoperative rehabilitation group
Arm Description
These patients will receive stoma care and stoma education beginning on postoperative day1.
The rehabilitation group will receive preoperative stoma education in addition
Outcomes
Primary Outcome Measures
duration of hospital stay
Compare duration from surgery until independent stoma self-care between preoperative rehabilitation using a stoma appliance group and traditional care group.
Secondary Outcome Measures
Assess anxiety and depression
Assess anxiety and depression according to HADS (Hospital Anxiety and Depression Scale).
0-7 normal 8-10 border line abnormal 11-21 abnormal
assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma
Assess the quality of life of those patients including physical, social/family, emotional, functional wellbeing, using FACT-C version 4 (Functional Assessment of Cancer Therapy-Colorectal) questionnaire.
recall period past 7 days response scale 5point Likert-type scale total a FACT-C score (functional assessment of cancer therapy -colorectal) range 0-136 the higher the score the better the quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05958433
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard postoperative education.
Arm Type
Active Comparator
Arm Description
These patients will receive stoma care and stoma education beginning on postoperative day1.
Arm Title
preoperative rehabilitation group
Arm Type
Experimental
Arm Description
The rehabilitation group will receive preoperative stoma education in addition
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation with stoma appliance
Intervention Description
The rehabilitation group will receive preoperative stoma education in addition, a water-filled ostomy appliance (50-100 ml) will be attached 48 hours before surgery. These pouches will not be removed until surgery, and the EST nurse will teach the patients preoperatively how to manage the ostomy appliance with similar standards as described in the usual postoperative stoma care.
Primary Outcome Measure Information:
Title
duration of hospital stay
Description
Compare duration from surgery until independent stoma self-care between preoperative rehabilitation using a stoma appliance group and traditional care group.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Assess anxiety and depression
Description
Assess anxiety and depression according to HADS (Hospital Anxiety and Depression Scale).
0-7 normal 8-10 border line abnormal 11-21 abnormal
Time Frame
9 monthes
Title
assess the effects of preoperative education using stoma appliance on quality of life in colorectal cancer patients with a stoma
Description
Assess the quality of life of those patients including physical, social/family, emotional, functional wellbeing, using FACT-C version 4 (Functional Assessment of Cancer Therapy-Colorectal) questionnaire.
recall period past 7 days response scale 5point Likert-type scale total a FACT-C score (functional assessment of cancer therapy -colorectal) range 0-136 the higher the score the better the quality of life
Time Frame
11 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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:
Those who undergo emergency surgery
Disoriented patients who cannot cooperate.
Patients with psychiatric disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nora gouda, lecturer
Phone
01005627897
Email
noraatef148@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa Wadie, Proffesor
Phone
01223703067
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly AliEldien, proffesor
Organizational Affiliation
Prof. Biostatistics & Cancer Epidemiology National Cancer Institute, Cairo University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Preoperative Rehabilitation With Stoma Appliance in Colorectal Cancer Patients
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