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Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model

Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03142854
Enrollment
429
Registered
2017-05-08
Start date
2017-05-01
Completion date
2017-08-30
Last updated
2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Cleansing Quality, Colonoscopy

Keywords

bowel preparation, colonoscopy, predictive model

Brief 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.

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 create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.

Interventions

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

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Intervention model description

Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients aged 18 or older * patients undergoing colonoscopy

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

Design outcomes

Primary

MeasureTime frameDescription
adequate bowel preparation rates between 2 groups.4 monthsadequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026