The Effect of Individualized Intervention on the Quality of Bowel Preparation

July 5, 2020 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

The Effect of Individualized Intervention on the Quality of Intestinal Preparation: a Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria：

  1. Aged between 18-75
  2. Patients with insufficient bowel preparation
  3. Patients without cognitive and communication barriers
  4. Informed consent, voluntary participation in the study Exclusion criteria：

1. Severe suppurative inflammation of anus and rectum 2. Severe acute enteritis and ischemic enteropathy 3. After partial colorectal resection 4. Peritonitis, intestinal perforation, extensive adhesion in the abdominal cavity and intestinal stenosis caused by various reasons 5. Large abdominal aneurysm, highly abnormal bowel flexion and late cancer with extensive intraperitoneal metastasis 6. Dysphagia or impaired swallowing reflex 7. Obvious gastroparesis or gastric outlet obstruction or intestinal obstruction 8. Severe chronic renal failure (creatinine clearance < 30 ml / min) 9. Severe congestive heart failure (NYHA class III or IV) 10. Uncontrolled hypertension (systolic pressure > 170 mm Hg, diastolic pressure > 100 mm Hg) 11. Toxic colitis or megacolon 12. Disorder of water and electrolyte 13. Pregnancy or lactation 14. Mental patients 15. Failure to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control group
The control group received routine intestinal preparation education.
ACTIVE_COMPARATOR: Experimental group
The experimental group was treated with routine intestinal preparation education and individualized intervention.
Behavioral: Individualized Intervention
In this study, patients with the risk factors of insufficient intestinal preparation were treated with individualized intervention (mainly from the following aspects: chronic constipation, intestinal preparation not strictly in accordance with the requirements, 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, etc., application of tricyclic antidepressants or anesthetics).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bowel preparation pass rate
Time Frame: During colonoscopy, endoscopists evaluated the quality of bowel preparation according to the Boston bowel preparation scale.
The Boston Bowel preparation scale ≥6 indicates qualified intestinal preparation.
During colonoscopy, endoscopists evaluated the quality of bowel preparation according to the Boston bowel preparation scale.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jinhai Wang, MD, The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shanxi, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200618

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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