Tailored Bowel Preparation According to Bristol Stool Form Scale

Bowel Cleansing Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415569
• Other study ID #: 2014SDU-QILU-G07
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2015
• Last updated: April 28, 2016
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bowel Cleansing Quality

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Shandong University	Binzhou People's Hospital, Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rate of non-compliance with instructions among 3 groups.		9 months	No
Secondary	Willingness to repeat bowel preparation among 3 groups.		9 months	No
Secondary	Polyp detection rate among 3 groups.		9 months	No
Secondary	Caecal intubation rate among 3 groups.		9 months	No
Secondary	Withdrawal time among 3 groups.		9 months	No