NCT03808649

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

January 12, 2019

Last Update Submit

January 18, 2019

Conditions

CTE

Outcome Measures

Primary Outcomes (2)

  • Clinical risk factors for inadequate small bowel distention

    Number of clinical risk factors for inadequate small bowel distention

    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%"

    4 month

Secondary Outcomes (1)

  • Side effects

    4 month

Study Arms (2)

Individualized group

ACTIVE COMPARATOR

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

Drug: 1500ml of 2.5% mannitolDrug: different volume of 2.5% mannitol

conventional group

EXPERIMENTAL

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

Drug: 1500ml of 2.5% mannitol

Interventions

1500ml of 2.5% mannitolDRUG

1500ml of 2.5% mannitol was used in experimental group

Individualized groupconventional group
different volume of 2.5% mannitolDRUG

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

Individualized group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing CT enterography

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Mannitol

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Yanqing Li, PhD, MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, PhD, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of Qilu Hospital

Study Record Dates

First Submitted

January 12, 2019

First Posted

January 17, 2019

Study Start

January 20, 2019

Primary Completion

March 20, 2019

Study Completion

July 20, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

CN(1)