Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation

Bowel Preparation Before Colonoscopy Clinical Trial

Official title:

Improved Bowel Cleansing Method for Colonoscopy Based on High Risk Population of Bowel Preparation#a Single-center,Endoscopist-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498714
• Other study ID #: WDRY2022-K082
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Renmin Hospital of Wuhan University
• Contact: Mingkai Chen, Ph.D & M.D
• Phone: 13720330580
• Email: chenmingkai[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the difference in bowel preparation quality between compound sodium picosulfate#CSP combined with lactulose and polyethylene glycol electrolyte#PEG combined with lactulose in high-risk population.

Description:

The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age >70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors.This is a single-center ,endoscopist-blinded study to compare the efficacy of CSP combined with lactulose and PEG combined with lactulose in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:Adults undergoing colonoscopy who have at least one risk factor: age>70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics.

Exclusion Criteria:

1. presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);

2. Patients with galactosemia;

3. hypersensitivity to any of the ingredients;

4. Pregnancy or lactation;

5. Use of lactulose,prokinetic agents or purgatives within 7 days;

6. Unwilling to sign informed consent.

Related Conditions & MeSH terms

• Bowel Preparation Before Colonoscopy

Intervention

Drug:
• PEG+lactulose
On the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM. On the day of the procedure, patients took 50 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.
• CSP+lactulose
On the day before colonoscopy , Patients took 50mL lactulose solution at 7:00 PM. And then Patients began to drink 150 mL of CSP at 8:00 PM ,followed by 2000ml of clarified liquid. On the day of the procedure, 4-6 hours before colonoscopy, patients took 50 mL lactulose solution and the remaining 150mL of CSP ,then followed by 750ml of clarified liquid .

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Scale	Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score =6 with each segmental BBPS=2, we regard it as adequate bowel preparation.	during colonoscopy
Secondary	Adenoma Detection Rate	Diagnosis was confirmed by histologic examination	2 days
Secondary	Polyp Detection Rate	Diagnosis was confirmed by histologic examination	2 days
Secondary	Rate of adverse events	adverse events, such as vomiting, nausea, headache, abdominal distention, abdominal pain.	2 days
Secondary	Cecal intubation rate	Colonoscopy reaches cecal region.	during colonoscopy
Secondary	Cecal intubation time	Colonoscopy reaches cecal region.	during colonoscopy
Secondary	Withdrawal time	The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.	during colonoscopy
Secondary	defecation frequency	Frequency of bowel movement.	2 days
Secondary	patient satisfaction Assessment	Patients' satisfaction score for bowel preparation (3 points: completely tolerable and very satisfied; 2 points: nausea and other discomfort, but still tolerable and satisfactory; 1: unable to tolerate, not satisfied); And whether the patient is willing to use the bowel cleansing program for colonoscopy;	2 days