CClinicalTrials.gg
Status unknownNCT03765216Updated Dec 5, 2018

Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

An interventional study of 2L Polyethylene Glycol (PEG) and 4L Polyethylene Glycol (PEG) in Bowel Preparation and Colonoscopy, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Shandong University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

Read the detailed description

Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.

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Conditions studied

  • Bowel Preparation
  • Colonoscopy
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In context

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients aged 18 or older
  • patients undergoing colonoscopy

Exclusion criteria

Exclusion Criteria:

  • patients with a history of colorectal surgery
  • patients with severe colonic stricture or obstructing tumor
  • patients with dysphagia
  • patients with compromised swallowing reflex or mental status
  • patients with significant gastroparesis or gastric outlet obstruction
  • patients with known or suspected bowel obstruction or perforation
  • patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
  • patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
  • patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
  • patients with inflammatory bowel disease or megacolon
  • patients with dehydration
  • patients with dehydration
  • patients with pregnancy or lactation
  • patients hemodynamically unstable
  • patients unable to give informed consent
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Group A: standard group

    Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.

    Drug: 2L Polyethylene Glycol (PEG)

  • Experimental
    Group B: tailored group

    Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage). Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.

    Drug: 2L Polyethylene Glycol (PEG) · Drug: 4L Polyethylene Glycol (PEG)

Interventions

  • Drug2L Polyethylene Glycol (PEG)

    Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen

    Also known as: Standard

  • Drug4L Polyethylene Glycol (PEG)

    High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen

    Also known as: High dose

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What researchers measure

Primary outcomes

  1. Adequate bowel preparation rates

    Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)

    Time frame: 2 months

Secondary outcomes

  1. Polyp detection rate

    Polyp detection rates between 2 groups

    Time frame: 2 months

07

Study locations

1 site
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Ji'nan, Shandong 250012, China
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References and documents

Individual participant data

Plan to share: Undecided — The individual participant data of this trial will be shared when necessary

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03765216
Lead sponsor
Shandong University
Responsible party
Yanqing Li (Vice President of Qilu Hospital, Shandong University) — Principal investigator
First posted
Dec 5, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Feb 28, 2019 (estimated)
Completion
Mar 15, 2019 (estimated)
Last update
Dec 5, 2018

Study contacts

Li Yanqing, PhD,MD
Contact
liyanqing@sdu.edu.cn
86-531-82169236
Li Yanqing, PhD,MD
principal investigator · Qilu Hospital, Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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