Skip to content

Tailored Bowel Preparation According to Bristol Stool Form Scale

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02415569
Enrollment
700
Registered
2015-04-14
Start date
2015-01-31
Completion date
2015-10-31
Last updated
2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Cleansing Quality

Keywords

bowel cleansing, bisacodyl, polyethyleneglycol, colonoscopy, the bristol stool form scale

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.

Interventions

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.

DRUG2L PEG-ELP and 10mg bisacodyl

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.

Sponsors

Qianfoshan Hospital
CollaboratorOTHER
Binzhou People's Hospital
CollaboratorOTHER
Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.9 monthsThis is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.

Secondary

MeasureTime 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026