Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model

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

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bowel Cleansing Quality Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group A: standard group

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

Group Type ACTIVE_COMPARATOR

Polyethylene Glycol (PEG)

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Polyethylene Glycol (PEG)

Intervention Type DRUG

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

Interventions

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Polyethylene Glycol (PEG)

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

Intervention Type DRUG

Polyethylene Glycol (PEG)

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

Intervention Type DRUG

Other Intervention Names

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High-dose Bowel Preparation Regimen

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No