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Tailored Bowel Preparation According to Bristol Stool Form Scale

Phase 4
Completed
Conditions
Bowel Cleansing Quality
Interventions
Drug: Standard Bowel Prep (2L PEG-ELP)
Drug: 2L PEG-ELP and 10mg bisacodyl
Registration Number
NCT02415569
Lead Sponsor
Shandong University
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
700
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group3Standard Bowel Prep (2L PEG-ELP)Subjects whose bristol stool forms are type 3 to 7, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.
group1Standard Bowel Prep (2L PEG-ELP)Subjects whose bristol stool forms are type 1 or 2, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.
group22L PEG-ELP and 10mg bisacodylSubjects 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 )
Primary Outcome Measures
NameTimeMethod
Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.9 months

This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.

Secondary Outcome Measures
NameTimeMethod
Willingness to repeat bowel preparation among 3 groups.9 months
Caecal intubation rate among 3 groups.9 months
Polyp detection rate among 3 groups.9 months
Rate of non-compliance with instructions among 3 groups.9 months
Withdrawal time among 3 groups.9 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

🇨🇳

Jinan, Shandong, China

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