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Completed

NCT Number: NCT02415569

Tailored Bowel Preparation According to Bristol Stool Form Scale

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Bowel Prep (2L PEG-ELP)

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.

2L PEG-ELP and 10mg bisacodyl

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.

Primary outcomes

  1. Difference of scores rating by Boston Bowel Preparation Scale among 3 groups.

    Time frame: 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 outcomes

  1. Rate of non-compliance with instructions among 3 groups.

    Time frame: 9 months

  2. Willingness to repeat bowel preparation among 3 groups.

    Time frame: 9 months

  3. Polyp detection rate among 3 groups.

    Time frame: 9 months

  4. Caecal intubation rate among 3 groups.

    Time frame: 9 months

  5. Withdrawal time among 3 groups.

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Binzhou People's Hospital
  • Qianfoshan Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2015
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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