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出境医 / 临床实验 / Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

Study Description
Brief Summary:
About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

Condition or disease Intervention/treatment Phase
Bowel Preparation Colonoscopy Drug: 2L Polyethylene Glycol (PEG) Drug: 4L Polyethylene Glycol (PEG) Not Applicable

Detailed Description:
Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 15, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Group A: standard group
Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.
 Drug: 2L Polyethylene Glycol (PEG)
Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen
Other Name: Standard
Experimental: Group B: tailored group

Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).

Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.

 Drug: 2L Polyethylene Glycol (PEG)
Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen
Other Name: Standard

Drug: 4L Polyethylene Glycol (PEG)
High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen
Other Name: High dose
Outcome Measures
Primary Outcome Measures :
  1. Adequate bowel preparation rates [ Time Frame: 2 months ]
    Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)


Secondary Outcome Measures :
  1. Polyp detection rate [ Time Frame: 2 months ]
    Polyp detection rates between 2 groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 or older
  • patients undergoing colonoscopy

Exclusion Criteria:

  • patients with a history of colorectal surgery
  • patients with severe colonic stricture or obstructing tumor
  • patients with dysphagia
  • patients with compromised swallowing reflex or mental status
  • patients with significant gastroparesis or gastric outlet obstruction
  • patients with known or suspected bowel obstruction or perforation
  • patients with severe chronic renal failure (creatinine clearance<30 ml/min)
  • 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 inflammatory bowel disease or megacolon
  • patients with dehydration
  • patients with dehydration
  • patients with pregnancy or lactation
  • patients hemodynamically unstable
  • patients unable to give informed consent
Contacts and Locations

Contacts
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Contact: Li Yanqing, PhD,MD 86-531-82169236 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Ji'nan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Li Yanqing, PhD,MD Qilu Hospital, Shandong University
Tracking Information
First Submitted Date  ICMJE December 4, 2018
First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 5, 2018
Estimated Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018) 		Adequate bowel preparation rates [ Time Frame: 2 months ]
Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018) 		Polyp detection rate [ Time Frame: 2 months ]
Polyp detection rates between 2 groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study
Official Title  ICMJE Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study
Brief Summary About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.
Detailed Description Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Bowel Preparation
  • Colonoscopy
Intervention  ICMJE
  • Drug: 2L Polyethylene Glycol (PEG)
    Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen
    Other Name: Standard
  • Drug: 4L Polyethylene Glycol (PEG)
    High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen
    Other Name: High dose
Study Arms  ICMJE
  • Active Comparator: Group A: standard group
    Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.
    Intervention: Drug: 2L Polyethylene Glycol (PEG)
  • Experimental: Group B: tailored group

    Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).

    Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.

    Interventions:
    • Drug: 2L Polyethylene Glycol (PEG)
    • Drug: 4L Polyethylene Glycol (PEG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 4, 2018) 		600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 15, 2019
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients aged 18 or older
  • patients undergoing colonoscopy

Exclusion Criteria:

  • patients with a history of colorectal surgery
  • patients with severe colonic stricture or obstructing tumor
  • patients with dysphagia
  • patients with compromised swallowing reflex or mental status
  • patients with significant gastroparesis or gastric outlet obstruction
  • patients with known or suspected bowel obstruction or perforation
  • patients with severe chronic renal failure (creatinine clearance<30 ml/min)
  • 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 inflammatory bowel disease or megacolon
  • patients with dehydration
  • patients with dehydration
  • patients with pregnancy or lactation
  • patients hemodynamically unstable
  • patients unable to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03765216
Other Study ID Numbers  ICMJE 2018SDU-QILU-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The individual participant data of this trial will be shared when necessary
Responsible Party Yanqing Li, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Yanqing, PhD,MD Qilu Hospital, Shandong University
PRS Account Shandong University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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