A Predictive Model for Inadequate Bowel Preparation

Bowel Preparation Clinical Trial

Official title:

A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704571
• Other study ID #: 2018SDU-QILU-G111
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2019
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: August 30, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-75 years undergoing colonoscopy

Exclusion Criteria:

• known or suspected bowel obstruction, stricture or perforation

• compromised swallowing reflex or mental status

• severe chronic renal failure(creatinine clearance < 30 ml/min)

• severe congestive heart failure (New York Heart Association class III or IV)

• uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)

• dehydration

• disturbance of electrolytes

• pregnancy or lactation

• hemodynamically unstable

• unable to give informed consent

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• Polyethylene Glycol
In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens. In the control group, all the patients are given routine regimens.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Bowel Preparation	The quality of bowel preparation is evaluated using BBPS.	10 months
Secondary	Adenoma Detection Rate	The proportion of patients from whom at least one adenoma can be detected.	10 months
Secondary	Polyp Detection Rate	The proportion of patients from whom at least one polyp can be detected.	10 months
Secondary	Adverse Events	Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on.	10 months