The Effect of Individualized Intervention on the Quality of Bowel Preparation

NCT04446195 | Unknown

• 1 other identifier: 20200618
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bowel Preparation Solutions

Outcome Measures

Primary Outcomes (1)

• Bowel preparation pass rate

  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.

Study Arms (2)

Control group

NO INTERVENTION

The control group received routine intestinal preparation education.

Experimental group

ACTIVE COMPARATOR

The experimental group was treated with routine intestinal preparation education and individualized intervention.

Behavioral: Individualized Intervention

Interventions

Individualized Intervention BEHAVIORAL

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).

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18-75
• Patients with insufficient bowel preparation
• Patients without cognitive and communication barriers

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

Location

Study Officials

• Jinhai Wang, MD

  The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an, Shanxi, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhai Wang, MD

CONTACT

+86-29-13609281113; jinhaiwang@hotmail.com

Yaqin Cai, MD

CONTACT

+86-29-13032920414; 1610779309@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 30, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-06

Locations

CN (1)