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

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

Study Overview

• Status: Completed
• Conditions: Bowel Cleansing Quality
• Intervention / Treatment: Drug: Standard Bowel Prep (2L PEG-ELP); Drug: Standard Bowel Prep (2L PEG-ELP); Drug: 2L PEG-ELP and 10mg bisacodyl

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.

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: group1; 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); 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.; Drug: Standard Bowel Prep (2L PEG-ELP); 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.
EXPERIMENTAL: group2; 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; 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.
ACTIVE_COMPARATOR: group3; 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); 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.; Drug: Standard Bowel Prep (2L PEG-ELP); 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Qianfoshan Hospital; Binzhou People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (ESTIMATE): April 14, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: colonoscopy; bowel cleansing; bisacodyl; polyethyleneglycol; the bristol stool form scale
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: 2014SDU-QILU-G07