Tailored Bowel Preparation According to Bristol Stool Form Scale

Study Overview
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Brief Summary
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The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

Detailed Description
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Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation. The Bristol stool form scale ( BSFS) was developed in 1988 by O'Donnell LJD et al and was widely applied in both gastrointestinal study and clinical practice. BSFS divides human stool into 7 different styles according to its moisture content. In our clinical work, we find that it is prone to gain poor bowel cleansing quality in patients who pass type 1or 2 stool. Unfortunately, there is lacking of study on tailored bowel preparation according to Bristol stool form scale. Thus, we intend to develop an easy, practical, BSFS based tailored bowel cleansing regimen, in order to serve clinical work and research.

Official Title
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Tailored Bowel Preparation According to Bristol Stool Form Scale: a Prospective, Randomized, Controlled, Investigator-blinded, Multicenter Study

Conditions
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Bowel Cleansing Quality

Intervention / Treatment
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* Drug: Standard Bowel Prep (2L PEG-ELP)
* Drug: 2L PEG-ELP and 10mg bisacodyl
* Drug: Standard Bowel Prep (2L PEG-ELP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older, scheduled to undergo elective outpatient colonoscopy, and were able to provide informed consent. Exclusion Criteria: history of colorectal surgery severe colonic stricture or obstructing tumour dysphagia compromised swallowing reflex or mental status significant gastroparesis or gastric outlet obstruction known or suspected bowel obstruction or perforation 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) inflammatory bowel disease or megacolon dehydration disturbance of electrolytes pregnancy or lactation haemodynamically unstable unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1<br>Subjects whose bristol stool forms are type 1 or 2, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure. | Drug: Standard Bowel Prep (2L PEG-ELP)<br>* Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure.<br>|
| Experimental: group2<br>Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure. ( 2L PEG-ELP and 10mg bisacodyl ) | Drug: 2L PEG-ELP and 10mg bisacodyl<br>* Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure.<br>|
| Active Comparator: group3<br>Subjects whose bristol stool forms are type 3 to 7, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure. | Drug: Standard Bowel Prep (2L PEG-ELP)<br>* Subjects whose bristol stool forms are type 3 to 7, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of scores rating by Boston Bowel Preparation Scale among 3 groups. | This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of non-compliance with instructions among 3 groups. |  | 9 months | 
| Willingness to repeat bowel preparation among 3 groups. |  | 9 months | 
| Polyp detection rate among 3 groups. |  | 9 months | 
| Caecal intubation rate among 3 groups. |  | 9 months | 
| Withdrawal time among 3 groups. |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel cleansing, bisacodyl, polyethyleneglycol, colonoscopy, the bristol stool form scale