Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

NCT04582942 | Completed

• 1 other identifier: 2019-X2-73
• Study Type: interventional
• Target: 2,028
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bowel Preparation Before Colonoscopy

Keywords

Colonoscopy; Lactulose; Polyethylene glycol; Bowel preparation

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 (7)

• Adenoma Detection Rate

  2 days

• Rate of adverse events

  2 days

• Cecal intubation rate

  during colonoscopy

• Cecal intubation time

  during colonoscopy

• Withdrawal time

  during colonoscopy

Study Arms (2)

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

PLACEBO COMPARATOR

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

Drug: PEG

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

EXPERIMENTAL

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

Drug: PEG+lactulose

Interventions

PEG 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.

Also known as: only used PEG

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

PEG+lactulose 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.

Also known as: PEG combined with lactulose

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults undergoing colonoscopy.

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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Wuhan Central Hospital: collaborator
• Wuhan Third Hospital: collaborator
• The General Hospital of Central Theater Command: collaborator
• The Third People's Hospital of Hubei Province: collaborator
• Wuhan Puren Hospital: collaborator
• Wuhan Puai Hospital: collaborator
• Tian You Hospital Affiliated to Wuhan University of Science and Technology: collaborator
• Wuhan Red Cross Hospital: collaborator

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Related Publications (5)

• 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.

  PMID: 25595062 BACKGROUND

• 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.

  PMID: 31295746 BACKGROUND

• 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.

  PMID: 28985630 BACKGROUND

• 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.

  PMID: 29533397 BACKGROUND

• 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.

  PMID: 26658804 BACKGROUND

MeSH Terms

Interventions

Lactulose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Mingkai Chen, M.D

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Department of Gastroenterology I

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 12, 2020
• Study Start: August 6, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

CN (1)