Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04446195 |
| Other study ID # |
20200618 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2020 |
| Est. completion date |
March 30, 2021 |
Study information
| Verified date |
June 2020 |
| Source |
Second Affiliated Hospital of Xi'an Jiaotong University |
| Contact |
Jinhai Wang, MD |
| Phone |
+86-29-13609281113 |
| Email |
jinhaiwang[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Colorectal cancer (CRC) is one of the most common malignant tumors in the clinic. Colonoscopy
is an important means of screening, diagnosis and treatment of colorectal diseases. The
accuracy of diagnosis and the safety of treatment are closely related to the quality of
intestinal preparation. Inadequate bowel preparation leads to poor effect of colonoscopy,
which will reduce the effectiveness and safety of colonoscopy, increase the difficulty and
time of colonoscopy, and increase the need of repeated colonoscopy. There are many factors
that lead to poor bowel preparation. Recently, a number of studies at home and abroad have
evaluated the risk factors related to insufficient bowel preparation. Obesity, men, older
age, previous colon surgery history, accompanied by other diseases (such as diabetes,
Parkinson's disease), taking antidepressants and other factors can affect the effect of bowel
preparation. Although the research of intestinal preparation intervention and education
methods has made a lot of progress, but in a series of reports, there are still a
considerable number of patients in colonoscopy problems of intestinal preparation. At
present, there are few researches on individualized intervention aiming at the risk factors
of inadequate bowel preparation in China, so it is urgent to explore individualized bowel
preparation scheme suitable for different populations. Therefore, the purpose of this
experiment is to study individualized dryness aiming at the risk factors of insufficient
bowel preparation in patients with the risk factors of insufficient bowel preparation The
effect of pre-treatment on the quality of intestinal preparation can provide reference for
improving the quality of intestinal preparation in patients with inadequate intestinal
preparation.
Description:
Colorectal cancer (CRC) is a malignant tumor originates from colorectal mucosa epithelium. It
is one of the most common malignant tumors in the world. Incidence rate of lung cancer is
second only to lung cancer and breast cancer worldwide. In recent years, with the continuous
improvement of people's living standard, changes in diet and diet structure and aging of
population, the incidence rate and mortality rate of colorectal cancer in China have been
increasing. A significant proportion of colorectal cancer patients have no characteristic
clinical symptoms and reported symptoms. Many colorectal cancers have reached the middle and
late stage when they are discovered, and their prognosis is poor. It can be seen that early
prevention of colorectal cancer is very important. Timely screening for colorectal adenomas
and endoscopic resection are the most effective measures to prevent colorectal cancer.
Colonoscopy is currently recognized as the gold standard for colorectal cancer screening,
which can not only detect early precancerous lesions, but also remove precancerous lesions
and block the formation of colorectal cancer.Colonoscopy is an important means of screening,
diagnosis and treatment of colonic diseases. The accuracy of diagnosis and the safety of
treatment are closely related to the quality of intestinal preparation. Adequate intestinal
preparation can make patients obtain higher intestinal cleanliness, ensure the integrity and
correctness of colonoscopy, improve the detection rate of polyps and adenomas, increase the
rate of cecal intubation and reduce the follow-up time The occurrence of adverse events such
as shortened interval, intestinal perforation and missed diagnosis is of great significance
for the realization of high-quality enteroscopy diagnosis and treatment.Bowel preparation is
not a simple cathartic process, it involves all aspects of communication between patients and
doctors. Good intestinal preparation includes following dietary restrictions before
examination, applying adequate amount of appropriate cathartic drugs during intestinal
preparation, waiting for the appropriate time interval between colonoscopies after intestinal
preparation, and appropriate amount of active drinking water, etc. Strict dietary restriction
and bowel cleaning are the necessary conditions to improve the quality of bowel preparation.
Kang x et al. Showed that 18% to 30.5% of patients had insufficient bowel preparation [.
Clinically, there may be more patients with poor bowel preparation. Inadequate bowel
preparation will lead to longer operation time, more difficult catheterization of cecum,
lower detection rate of adenoma and shorter follow-up time, which will increase the cost of
colonoscopy. At present, Boston scale is widely used to evaluate the quality of intestinal
preparation. The Boston scale divides the colon into three segments (cecum and ascending
colon; hepatic, transverse and splenic flexure; descending, sigmoid and rectum). According to
the worst-case to clean score, it is divided into four grades (0-3), with a total score of
0-9. Boston scale ≥ 6 points indicates that the intestinal preparation is qualified.There are
many factors that lead to poor bowel preparation. Recently, a number of studies at home and
abroad have evaluated the risk factors related to insufficient bowel preparation. Obesity,
men, older age, previous colon surgery history, accompanied by other diseases (such as
diabetes, Parkinson's disease), taking antidepressants and other factors can affect the
effect of bowel preparation. Combined with the literature at home and abroad and the
characteristics of Chinese people, the guidelines for gut preparation related to the
diagnosis and treatment of digestive endoscopy in China suggest that the following factors
are the risk factors for inadequate gut preparation in China: chronic constipation, failure
to prepare the gut in strict accordance with the requirements (such as high fiber diet before
operation, insufficient peg intake), body mass index > 25 kg / m2, age > 70 years old, colon
surgery history With other diseases (such as diabetes, Parkinson's disease, history of stroke
or spinal cord injury, etc.), application of tricyclic antidepressants or anesthetics.In
addition, the guidelines for gut preparation related to the diagnosis and treatment of
digestive endoscopy in China suggest that if the patient's gut preparation is not sufficient
during the endoscopic examination, it should be actively evaluated and remedial measures
should be taken or the endoscopic examination should be rescheduled. For the patients with
the risk factors of insufficient intestinal preparation, other auxiliary measures can be
taken to improve the intestinal preparation, such as the 4L peg program, low residue diet
three days before endoscopic diagnosis and treatment, gastrointestinal motility promoting
drugs, etc.; in addition, it is also of great value to further strengthen the education
related to the optimization of intestinal preparation for the patients.In recent years, with
the continuous development of China's economy, the continuous improvement of people's living
conditions, and the continuous strengthening of patients' health awareness, colonoscopy has
become one of the necessary items for many people's routine physical examination. However, in
most medical institutions, when guiding patients to prepare for intestinal tract, there are
some problems, such as lack of management, lack of detailed explanation, and complex process.
These problems lead to the lack of understanding of intestinal tract preparation process for
patients, thus affecting the preparation work before patients' examination and the follow-up
treatment plan. Therefore, it has become one of the most important issues to study how to
improve the intervention and guidance methods of patients' intestinal preparation and improve
the quality of patients' intestinal preparation.Although the research of intestinal
preparation intervention and education methods has made a lot of progress, various methods of
intervention and guidance for patients before colonoscopy have been proposed at home and
abroad to improve the quality of intestinal preparation. However, in a series of reports,
there are still a considerable number of patients in the colonoscopy problems of intestinal
preparation.At present, there are few researches on individualized intervention aiming at the
risk factors of inadequate bowel preparation in China, so it is urgent to explore
individualized bowel preparation programs suitable for different populations. Therefore, in
this experiment, we designed individualized intervention for patients with insufficient bowel
preparation (mainly from the following aspects: chronic constipation, not strictly in
accordance with the requirements Bowel preparation, body mass index > 25 kg / m2, age > 70
years old, with other diseases such as diabetes, Parkinson's disease, history of stroke or
spinal cord injury, application of tricyclic antidepressants or anesthetics). The purpose of
the study is to study the effect of individualized intervention on the quality of intestinal
preparation for patients with insufficient intestinal preparation, and to provide reference
for improving the quality of intestinal preparation for patients with insufficient intestinal
preparation.
