Individualized Volume of Oral Contrast Agent in CT Enterography

Shandong University180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

180

Conditions

CTE

Interventions

1500ml of 2.5% mannitolDRUG

1500ml of 2.5% mannitol was used in experimental group

different volume of 2.5% mannitolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

Clinical risk factors for inadequate small bowel distention

Number of clinical risk factors for inadequate small bowel distention

Time frame: 2 month

Adequate small bowel distention

The assessment system includes four parts 1. Whether the contrast reached the caecum is evaluate and recorded as "yes" or "no" 2. The overall presence of inhomogeneous contrast is evaluated and recorded as "yes" or "no" 3. The maximum dimension of a single loop in each quadrant was recorded. 4. The scale of loops of small bowel distended are evaluated and recorded as "0%-25%","26%-50%","51%-75%","75%-100%"

Time frame: 4 month

Secondary Outcomes

Side effects

Side effects in 2 groups The degree of nausea, emesis, diarrhea, abdominal distension and cramp following ingestion are scored on a scale ranging from 0 to 4, in which a higher score represents a higher level of these targets.

Time frame: 4 month

Central Contacts

Yanqing Li, PhD, MD

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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