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Bowel Preparation Before ColonoscopyNCT04582942

Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

A study testing PEG and PEG+lactulose in people with Bowel Preparation Before Colonoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bowel Preparation Before Colonoscopy
What is being tested?
PEG and PEG+lactulose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,028 participants
Where
1 siteChina
Study dates
6 Aug 2020to 15 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults undergoing colonoscopy.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

Other trials in China

About this study

Official title: Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification：a Multicenter, Endoscopist-blinded Randomized Controlled Trial

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.

Read the 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 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.

Being tested
PEG, PEG+lactulose
Keywords
Colonoscopy, Lactulose, Polyethylene glycol, Bowel preparation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEGDrug

    Also called only used 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.

  • PEG+lactuloseDrug

    Also called PEG combined with 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.

Study groups in NCT04582942
Study groupRoleWhat they receive
PEG (low-risk patients and high-risk patients)Placebo comparatorThe dosing regimen of low-risk patients and high-risk patients will only be PEG.
Receives: Drug: PEG
PEG+lactulose (low-risk patients and high-risk patients)ExperimentalThe dosing regimen of low-risk patients and high-risk patients will be PEG combined with lactulose.
Receives: Drug: PEG+lactulose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: during colonoscopy

Secondary outcomes (7)

  1. Adenoma Detection Rate

    Diagnosis was confirmed by histologic examination

    Measured: 2 days

  2. Rate of adverse events

    adverse events, such as vomiting, nausea, headache, abdominal distention,abdominal pain.

    Measured: 2 days

  3. Cecal intubation rate

    Colonoscopy reaches cecal region.

    Measured: during colonoscopy

  4. Cecal intubation time

    Colonoscopy reaches cecal region.

    Measured: during colonoscopy

  5. Withdrawal time

    The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.

    Measured: during colonoscopy

  6. defecation frequency

    Frequency of bowel movement.

    Measured: 2 days

  7. Willingness to repeat bowel preparation

    The number of patients have a willingness to undergo a repeated bowel preparation if needed.

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start6 Aug 2020
  3. Primary completion15 Aug 2021
  4. Study completion15 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
2,028 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582942
Sponsor's protocol ID
2019-X2-73
Status last verified
Dec 2022
First submitted
25 Sep 2020
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25595062

  • 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.

    PubMed 31295746

  • 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.

    PubMed 28985630

  • 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.

    PubMed 29533397

  • 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.

    PubMed 26658804

Questions about this trial

What is this clinical trial studying?

A study testing PEG and PEG+lactulose in people with Bowel Preparation Before Colonoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boston Bowel Preparation Scale (time frame: during colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582942, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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