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Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

NCT ID: NCT04582942

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2028 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2021-08-15

Brief Summary

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The purpose of this study is to evaluate the efficacy of polyethylene glycol（PEG） combined with lactulose for bowel preparation before colonoscopy in low-risk patients and high-risk patients.

Detailed Description

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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 and considered as low risk if they did not have any of these risk factors.This is a multicenter, endoscopist-blinded study to compare the efficacy of PEG combined with lactulose and PEG alone 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.

Conditions

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Bowel Preparation Before Colonoscopy

Keywords

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Colonoscopy Lactulose Polyethylene glycol Bowel preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients scheduled for colonoscopy were stratified into low- and high-risk patients based on the inclusion criteria. Low- and high-risk patients were randomized to the PEG alone or lactulose combined with PEG group respectively.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
The allocation assignment of patients was performed by a designated technician at each center based on a computer-generated random sequence. The designated technician was not involved in the colonoscopy procedure.

Study Groups

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PEG (low-risk patients and high-risk patients)

The dosing regimen of low-risk patients and high-risk patients will only be PEG.

Group Type PLACEBO_COMPARATOR

PEG

Intervention Type DRUG

Patients began to drink 1 L of PEG at 8:00 PM on the day before colonoscopy at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took the remaining 2 L of PEG 4-6 hours before colonoscopy.

PEG+lactulose (low-risk patients and high-risk patients)

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

Group Type EXPERIMENTAL

PEG+lactulose

Intervention Type DRUG

On the day before colonoscopy , Patients took 45 mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took 45 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.

Interventions

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PEG

Patients began to drink 1 L of PEG at 8:00 PM on the day before colonoscopy at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took the remaining 2 L of PEG 4-6 hours before colonoscopy.

Intervention Type DRUG

PEG+lactulose

On the day before colonoscopy , Patients took 45 mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took 45 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.

Intervention Type DRUG

Other Intervention Names

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only used PEG PEG combined with lactulose

Eligibility Criteria

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Inclusion Criteria

\- Adults undergoing colonoscopy.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Wuhan Central Hospital

OTHER

Sponsor Role collaborator

Wuhan Third Hospital

OTHER

Sponsor Role collaborator

The General Hospital of Central Theater Command

OTHER

Sponsor Role collaborator

The Third People's Hospital of Hubei Province

OTHER

Sponsor Role collaborator

Wuhan Puren Hospital

OTHER

Sponsor Role collaborator

Wuhan Puai Hospital

UNKNOWN

Sponsor Role collaborator

Tian You Hospital Affiliated to Wuhan University of Science and Technology

UNKNOWN

Sponsor Role collaborator

Wuhan Red Cross Hospital

UNKNOWN

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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ChenMingkai

Chief physician of Department of Gastroenterology I

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingkai Chen, M.D

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

References

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ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.

Reference Type BACKGROUND
PMID: 25595062 (View on PubMed)

Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11.

Reference Type BACKGROUND
PMID: 31295746 (View on PubMed)

Bai Y, Fang J, Zhao SB, Wang D, Li YQ, Shi RH, Sun ZQ, Sun MJ, Ji F, Si JM, Li ZS. Impact of preprocedure simethicone on adenoma detection rate during colonoscopy: a multicenter, endoscopist-blinded randomized controlled trial. Endoscopy. 2018 Feb;50(2):128-136. doi: 10.1055/s-0043-119213. Epub 2017 Oct 6.

Reference Type BACKGROUND
PMID: 28985630 (View on PubMed)

Kang X, Zhao L, Zhu Z, Leung F, Wang L, Wang X, Luo H, Zhang L, Dong T, Li P, Chen Z, Ren G, Jia H, Guo X, Pan Y, Guo X, Fan D. Same-Day Single Dose of 2 Liter Polyethylene Glycol is Not Inferior to The Standard Bowel Preparation Regimen in Low-Risk Patients: A Randomized, Controlled Trial. Am J Gastroenterol. 2018 Apr;113(4):601-610. doi: 10.1038/ajg.2018.25. Epub 2018 Mar 13.

Reference Type BACKGROUND
PMID: 29533397 (View on PubMed)

Lu J, Cao Q, Wang X, Pu J, Peng X. Application of Oral Lactulose in Combination With Polyethylene Glycol Electrolyte Powder for Colonoscopy Bowel Preparation in Patients With Constipation. Am J Ther. 2016 Jul-Aug;23(4):e1020-4. doi: 10.1097/MJT.0000000000000351.

Reference Type BACKGROUND
PMID: 26658804 (View on PubMed)

Other Identifiers

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2019-X2-73

Identifier Type: -

Identifier Source: org_study_id