Individualized Volume of Oral Contrast Agent in CT Enterography

Not Applicable

• Conditions: CTE
• Interventions: Drug: 1500ml of 2.5% mannitol; Drug: different volume of 2.5% mannitol

• Registration Number: NCT03808649
• Lead Sponsor: Shandong University

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-12
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Last Update Submitted: 2019-01-18
• Study Start: 2019-01-20
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-03-20
• Study Completion: 2019-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized group	different volume of 2.5% mannitol	Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.
Individualized group	1500ml of 2.5% mannitol	Participants are given different volume of a preparation of mannitol based on BMI as oral contrast agent over an hour prior to the examination.
conventional group	1500ml of 2.5% mannitol	Participants are given 1500ml of a preparation of mannitol as oral contrast agent over an hour prior to the examination.

Primary Outcome Measures

Name	Time	Method
Adequate small bowel distention	4 month	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%"
Clinical risk factors for inadequate small bowel distention	2 month	Number of clinical risk factors for inadequate small bowel distention

Secondary Outcome Measures

Name	Time	Method
Side effects	4 month	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.

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China