Individualized Volume of Oral Contrast Agent in CT Enterography

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2019-07-20

Brief Summary

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Small bowel distension is mandatory for the assessment of the bowel wall in CT enterography, but some patients were sufferring inadequate small bowel distension. So, it is important to prescribe personalized regimen according to patient's personal characteristics.

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Detailed Description

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CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. Small bowel distension is mandatory for the assessment of the bowel wall. So, it is important to find clinical risk factors for inadequate small bowel distension and prescribe personalized regimen according to patient's personal characteristics to reduce patient acceptance.

Conditions

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CTE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Individualized group

Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.

Group Type ACTIVE_COMPARATOR

1500ml of 2.5% mannitol

Intervention Type DRUG

1500ml of 2.5% mannitol was used in experimental group

different volume of 2.5% mannitol

Intervention Type DRUG

different volume of 2.5% mannitol based on BMI was used in active comparator group

conventional group

Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination.

Group Type EXPERIMENTAL

1500ml of 2.5% mannitol

Intervention Type DRUG

1500ml of 2.5% mannitol was used in experimental group

Interventions

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1500ml of 2.5% mannitol

1500ml of 2.5% mannitol was used in experimental group

Intervention Type DRUG

different volume of 2.5% mannitol

different volume of 2.5% mannitol based on BMI was used in active comparator group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing CT enterography

Exclusion Criteria

* patients with a history of GI surgery
* patients with known or suspected bowel obstruction or perforation
* 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 acute upper GI bleeding
* patients with severe inflammatory bowel disease or megacolon
* patients with documented allergy to intravascular contrast agent
* patients with pregnancy or lactation
* patients hemodynamically unstable
* patients unable to give informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No