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Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

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ClinicalTrials.gov Identifier: NCT03765216
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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 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

Resource links provided by the National Library of Medicine


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




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



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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

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): NCT03765216


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

Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Ji'nan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
Principal Investigator: Li Yanqing, PhD,MD Qilu Hospital, Shandong University

Responsible Party: Yanqing Li, Vice President of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT03765216     History of Changes
Other Study ID Numbers: 2018SDU-QILU-09
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The individual participant data of this trial will be shared when necessary

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No