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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Preparation Before Colonoscopy
• Intervention / Treatment: Drug: PEG+lactulose; Drug: CSP＋lactulose

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingkai Chen, Ph.D & M.D; Phone Number: 13720330580; Email: chenmingkai@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: the control group; The dosing regimen of high-risk patients will be PEG combined with lactulose.	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.; Other Names: PEG combined with lactulose
EXPERIMENTAL: CSP+lactulose group; The dosing regimen of high-risk patients will be CSP combined with lactulose.	Drug: 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 .; Other Names: CSP combined with lactulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Colonoscopy; Polyethylene glycol; Lactulose; Bowel Preparation; Compound Sodium Picosulfate
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: WDRY2022-K082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No