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A Randomized Controlled Trial of Tailored Bowel Preparation Based on A Predictive Model

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ClinicalTrials.gov Identifier: NCT03704571
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

Brief Summary:
We aim to develop a predictive model to distinguish patients at risk for inadequate bowel preparation, and to compare adequate bowel preparation rate, adenoma detection rate and adverse events between tailored bowel preparation group and routine bowel preparation group.

Condition or disease Intervention/treatment Phase
Bowel Preparation Drug: Polyethylene Glycol Phase 4

Detailed Description:

Colonoscopy is considered the gold standard for colorectal cancer screening by detecting and removing precancerous lesions. Inadequate bowel preparation is associated with higher adenoma miss rate, longer procedure time, patient discomfort, and increased cost. Many risk factors have been identified to cause inadequate bowel preparation. However, the predictors are not consistent among current models. It can be explained that different races, diet and medication use, etc. result in the inconsistence.

There is no study focused on the predictive model before colonoscopy in China. Therefore, the purpose of this study is to develop and validate a predictive model to distinguish patients with high risk of inadequate bowel preparation who may benefit from intensified bowel preparation regimens and improve the quality of bowel preparation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized Controlled Trial of Tailored Bowel Preparation Based on A Predictive Model for Inadequate Bowel Preparation
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tailored Group
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 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy. All the patients drink 30ml simeticone mixed in the last cup of PEG.
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. All the patients are given 30ml simethicone before colonoscopy.


Active Comparator: Control Group
In the control group, all the patients only drank single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min. All the patients drink 30ml simeticone mixed in the last cup of PEG.
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. All the patients are given 30ml simethicone before colonoscopy.





Primary Outcome Measures :
  1. Quality of Bowel Preparation [ Time Frame: 10 months ]
    The quality of bowel preparation is evaluated using BBPS scale.


Secondary Outcome Measures :
  1. Adenoma Detection Rate [ Time Frame: 10 months ]
    The proportion of patients from whom at least one adenoma can be detected.

  2. Polyp Detection Rate [ Time Frame: 10 months ]
    The proportion of patients from whom at least one polyp can be detected.

  3. Adverse Events [ Time Frame: 10 months ]
    Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-75 years undergoing afternoon 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704571


Contacts
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Contact: Xiuli Zuo, MD, PhD 15588818685 zuoxiuli@sina.com

Locations
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China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, MD, PhD Qilu Hospital of Shandong University

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Responsible Party: Xiuli Zuo, director of Qilu Hospital gastroenterology department, Shandong University
ClinicalTrials.gov Identifier: NCT03704571     History of Changes
Other Study ID Numbers: 2018SDU-QILU-G111
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuli Zuo, Shandong University:
Predictive Model
Inadequate Bowel Preparation
Tailored Bowel Preparation