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

Not Applicable

• Conditions: Bowel Preparation Before Colonoscopy
• Interventions: Drug: PEG+lactulose; Drug: CSP＋lactulose

• Registration Number: NCT05498714
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-18
• Status Verified: 2022-08
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group	PEG+lactulose	The dosing regimen of high-risk patients will be PEG combined with lactulose.
CSP+lactulose group	CSP＋lactulose	The dosing regimen of high-risk patients will be CSP combined with lactulose.

Primary Outcome Measures

Name	Time	Method
Boston Bowel Preparation Scale	during colonoscopy	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.

Secondary Outcome Measures

Name	Time	Method
Adenoma Detection Rate	2 days	Diagnosis was confirmed by histologic examination
Rate of adverse events	2 days	adverse events, such as vomiting, nausea, headache, abdominal distention, abdominal pain.
Cecal intubation rate	during colonoscopy	Colonoscopy reaches cecal region.
Polyp Detection Rate	2 days	Diagnosis was confirmed by histologic examination
defecation frequency	2 days	Frequency of bowel movement.
Cecal intubation time	during colonoscopy	Colonoscopy reaches cecal region.
Withdrawal time	during colonoscopy	The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.
patient satisfaction Assessment	2 days	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;

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China