A Predictive Model for Inadequate Bowel Preparation

NCT03704571 — Not applicable, Completed, 429 participants, Shandong University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03704571
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	429 (Actual)
Sponsor	Shandong University (Other)
Conditions	Bowel Preparation
Interventions	Polyethylene Glycol (Drug)
Dates	start 2018-11-01, primary completion 2019-07-31, completion 2019-08-30, first posted 2018-10-15, last updated 2019-11-01
Locations	1 site in China

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Tailored Group	Experimental	Drug: Polyethylene Glycol	In the tailored group, high-risk patients are instructed to drink the first 2 L of Polyethylene Glycol (PEG) at 19:00-21:00 hours on the day before colonoscopy at a rate of 250 ml every 15 min. On the day of the procedure, they take another 2 L PEG 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy.
Control Group	Active comparator	Drug: Polyethylene Glycol	In the control group, all the patients drink single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min.

Polyethylene Glycol (Drug): 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.

+Outcome measures

Primary outcomes

Quality of Bowel Preparation [10 months]: The quality of bowel preparation is evaluated using BBPS.

Secondary outcomes

Adenoma Detection Rate [10 months]: The proportion of patients from whom at least one adenoma can be detected.
Polyp Detection Rate [10 months]: The proportion of patients from whom at least one polyp can be detected.
Adverse Events [10 months]: Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Qilu Hospital of Shandong University	Jinan, Shandong	China

+Investigators

Xiuli Zuo, MD, PhD, Principal investigator, Qilu Hospital of Shandong University

My Notes

Public

To Read Reading Read