NCT05498714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 10, 2022

Last Update Submit

August 24, 2022

Conditions

Bowel Preparation Before Colonoscopy

Keywords

ColonoscopyBowel PreparationPolyethylene glycolCompound Sodium PicosulfateLactulose

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Adenoma Detection Rate

    2 days

  • Polyp Detection Rate

    2 days

  • Rate of adverse events

    2 days

  • Cecal intubation rate

    during colonoscopy

  • Cecal intubation time

    during colonoscopy

  • +3 more secondary outcomes

Study Arms (2)

the control group

ACTIVE COMPARATOR

The dosing regimen of high-risk patients will be PEG combined with lactulose.

Drug: PEG+lactulose

CSP+lactulose group

EXPERIMENTAL

The dosing regimen of high-risk patients will be CSP combined with lactulose.

Drug: CSP＋lactulose

Interventions

PEG+lactuloseDRUG

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.

Also known as: PEG combined with lactulose
the control group
CSP＋lactuloseDRUG

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 .

Also known as: CSP combined with lactulose
CSP+lactulose group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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);
  • Patients with galactosemia;
  • hypersensitivity to any of the ingredients;
  • Pregnancy or lactation;
  • Use of lactulose,prokinetic agents or purgatives within 7 days;
  • Unwilling to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Interventions

Lactulose

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Mingkai Chen, Ph.D & M.D

    Renmin Hospital of Wuhan University

    STUDY DIRECTOR

Central Study Contacts

Mingkai Chen, Ph.D & M.D

CONTACT

13720330580chenmingkai@whu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 12, 2022

Study Start

July 18, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Locations

CN(1)