Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04943822 |
| Other study ID # |
fung |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
June 2022 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Colorectal cancer is the third leading cause of cancer-related deaths in Taiwan.
In the United States, colorectal cancer is the third most common cancer diagnosis and
mortality.
According to the databases of the Bureau of National Health Insurance (BNHI), in 2003-2006, a
total of 15,805 patients with colorectal surgery were included, and 27.11% were treated with
ostomy, while 90.45% were colostomy and 9.55% were ileostomy.
The domestic and foreign researches related to enterostomy mostly use cross-sectional
research methods. The quality of life, knowledge of self-care and self-care needs of
different postoperative methods of colorectal cancer have not been specifically improved for
patients with enterostomy. The research on self-care ability and quality of life is for
reference. In other countries, enterostomy care has gradually moved from medical institutions
to community care, but community nurses generally have no relevant care skills. Advances in
mobile technology such as smartphones and other mobile applications have created more
opportunities for individuals to receive health-related treatments, anytime, anywhere and
anywhere. In the United States, 93% of adult gastroenterology patients have smartphones in
medical teaching hospitals, and most of them are interested in using health-related
applications. In addition, previous studies have shown the potential benefits and efficacy of
mobile devices for self-care patients in diabetes, obesity and cancer. However, there are
limited studies on the feasibility and effectiveness of mobile applications for enterostomy
care. Researchers want to explore the effectiveness of mobile device intervention on home
self-care ability and quality of life of patients with intestinal stoma.
Description:
1. Background and research purpose Colorectal cancer has been ranked first in the nation's
cancer incidence for 11 consecutive years. Clinically, the surgical treatment of rectal
cancer is more difficult than that of colorectal cancer. On the one hand, it is the
anatomical location factor. Unlike colorectal cancer, which is located in the abdominal
cavity, rectal cancer is located in the narrower pelvic cavity with many bones
surrounding it. In particular, the pelvic cavity of men is smaller than that of women,
so the space available for surgery is relatively smaller than that of the large
intestine. Cancer is much less. On the other hand is the consideration of preserving the
anus. When removing a tumor that grows in the colon, there is basically no question of
whether to preserve the anus or not, because the large intestine is very long. However,
in order to clean the tumor, the doctor will leave a certain safe distance between the
front and rear ends of the tumor, that is, an extra 5-10 cm of cut. However, for rectal
tumors, most clinically patients want to preserve the anus. Therefore, the current safe
distance from the end of the tumor during rectal cancer resection is best to exceed 1
cm.
Therefore, for patients with rectal cancer, the way of defecation will definitely change
after surgery, but the impact will be large or small. It is generally recommended to
adjust the diet, such as reducing the intake of fiber such as fruits and vegetables to
reduce bowel movements. Some patients think that the uncertainty of dietary restrictions
and defecation will affect the quality of life, and they choose permanent artificial
anus. Although patients with colorectal cancer usually do not need to remove the anus,
they sometimes need temporary artificial anus, such as obstructive colorectal cancer. ,
First do a temporary artificial anus to help defecation, the purpose is to reduce
pressure, let the swollen belly disappear, and then perform surgery to remove the tumor
and remove the artificial anus. Although this artificial anus is only temporary, it is
not permanent. Among them, about 21% to 70% of enterostomy patients will have some types
of complications. These complications are related to stoma dysfunction, insufficient
stoma positioning and poor self-care ability. It may cause dermatitis, bleeding,
prolapse, necrosis, hernia, edema, waste including leakage, tracheal hernia, stenosis
and retraction. Nowadays, advances in mobile technology, such as mobile applications
such as smartphones, have created more opportunities for individuals to treat
health-related treatments, anytime, anywhere.
2. Research motivation The use of apps as a tool for teaching, nursing and diagnosing skin
lesions is a very innovative tool that allows learners to generate interest and
motivation to learn more, because the use of apps on mobile devices in the health care
sector is higher than that of books. Out of 45%-85%. The purpose of this study is to
investigate the effectiveness of using mobile devices to intervene in the self-care
ability and quality of life of patients with intestinal stoma.
3. Research design and objects A single blind-experimental design is adopted. First, those
who meet the acceptance criteria and are willing to participate in the research are
selected and assigned to the experimental and control groups by random assignment by the
computer random number table. It is estimated that 2 people will be needed Nursing staff
were admitted in the rectal anal treatment room. Participants were randomly assigned to
receive routine discharge care and mobile device guidance or routine outpatient
follow-up. Data were collected before the patient was discharged, 1 month, 2 months and
4 months after discharge . The structured questionnaire is filled in by the patient or
the researcher.
4. statistical methods Descriptive statistics, including frequency distribution and
percentage, average and standard deviation, median and interquartile range, and other
data to describe the distribution of data; first use the Kolmogorov-Smirnov test to
determine whether the data conform to normality Distribution; univariate analysis adopts
independent-sample t test or Mann-Whitney U test to compare the difference between the
experimental group and the control group in the continuous variables collected,
Chi-square test (chi-square test) or Fisher's exact test (Fisher's exact test) compares
the difference between the categorical variables collected in the experimental group and
the control group; further, binary logistic regression and stepwise regression are used.
Regression screening mode method is used to analyze multiple variables to find out the
important explanatory factors related to the involvement of mobile devices in personal
attributes, self-care ability and quality of life.
