Tailored Bowel Preparation According to Bristol Stool Form Scale

NCT ID: NCT02415569

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Bowel Cleansing Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

group1

Subjects whose bristol stool forms are type 1 or 2, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.

Group Type: EXPERIMENTAL

Standard Bowel Prep (2L PEG-ELP)

Intervention Type: DRUG

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.

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 )

Group Type: EXPERIMENTAL

2L PEG-ELP and 10mg bisacodyl

Intervention Type: DRUG

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.

group3

Subjects whose bristol stool forms are type 3 to 7, will receive standard bowel prep (2L PEG-ELP) the same-day of procedure.

Group Type: ACTIVE_COMPARATOR

Standard Bowel Prep (2L PEG-ELP)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Binzhou People's Hospital

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Vice president of Qilu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

li yanqing, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

2014SDU-QILU-G07

Identifier Type: -

Identifier Source: org_study_id