2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation

NCT01865916 | Completed Phase 4

• 1 other identifier: H13-00502
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority trial. The purpose of our study is to determine if using a 2-litre mixture in combination with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre PegLyte based preparations with an added laxative agent are commonly used for colonoscopies in outpatient settings. If the investigators discover that a 2-litre mixture with either the tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be able to experience fewer side effects and be less troubled by the preparation while still allowing a good view of the colon.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Bowel cleansing efficacy as rated by a Boston Bowel Preparation Scale score of greater than 8

  The BBPS is a relatively new, validated scoring system assessing cleanliness of three segments of the colon (left colon, transverse, and right colon). The total is a 10 point scale (0-9) that grades each segment of the colon from 0-3. A segment score of 0 describes: 'unprepared colon segment with mucosa not well seen due to solid stool that cannot be cleared'. Segment score 1: 'portion of mucosa of the colon segment seen, but other areas of the colon are not well seen due to staining, residual stool and/or opaque liquid'. Segment score 2: 'minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well'. Segment score 3: 'entire mucosa of the colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid'. In this study, we define an excellent equivalent BBPS score as 8 or 9. Scores of 7 or above are generally felt to provide a good visualization of the colon.

  20 hours

Secondary Outcomes (1)

• Patient tolerability to each 2L product

  20 hours

Study Arms (2)

2 Liters Bi-Peglyte

ACTIVE COMPARATOR

Subjects will be asked to take split dose of 2 Liters PEG + 15mg bisacodyl for bowel preparation the day before colonoscopy.

Drug: Polyethylene Glycol (PEG) and 15 mg Bisacodyl

2 Liters Moviprep

EXPERIMENTAL

Subject will be asked to take split dose of 2 Liters PEG + ascorbic acid for bowel preparation the day before colonoscopy

Drug: Polyethylene Glycol (PEG) + ascorbic acid

Interventions

Polyethylene Glycol (PEG) and 15 mg Bisacodyl DRUG

Subjects will be asked to take split dose of 2L PEG and 3 tablets of 5 mg Bisacodyl

Also known as: Bi-Peglyte

2 Liters Bi-Peglyte

Polyethylene Glycol (PEG) + ascorbic acid DRUG

Subjects will be asked to take split dose of 2L PEG and vitamin C

Also known as: Moviprep

2 Liters Moviprep

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults (≥ 19 years of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study.

You may not qualify if:

• those with constipation,
• suspected or known small bowel obstruction,
• severe inflammatory bowel disease, and
• any history of colonic resection.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (7)

• Beck DE, Harford FJ, DiPalma JA. Comparison of cleansing methods in preparation for colonic surgery. Dis Colon Rectum. 1985 Jul;28(7):491-5. doi: 10.1007/BF02554091.

  PMID: 4017808 BACKGROUND

• American Society of Colon and Rectal Surgeons (ASCRS); American Society for Gastrointestinal Endoscopy (ASGE); Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc. 2006 Jul;20(7):1147-60. doi: 10.1007/s00464-006-0152-y. Epub 2006 Jun 8. No abstract available.

  PMID: 16763922 BACKGROUND

• Hsu CW, Imperiale TF. Meta-analysis and cost comparison of polyethylene glycol lavage versus sodium phosphate for colonoscopy preparation. Gastrointest Endosc. 1998 Sep;48(3):276-82. doi: 10.1016/s0016-5107(98)70191-9.

  PMID: 9744604 BACKGROUND

• Curran MP, Plosker GL. Oral sodium phosphate solution: a review of its use as a colorectal cleanser. Drugs. 2004;64(15):1697-714. doi: 10.2165/00003495-200464150-00009.

  PMID: 15257632 BACKGROUND

• Vanner SJ, MacDonald PH, Paterson WG, Prentice RS, Da Costa LR, Beck IT. A randomized prospective trial comparing oral sodium phosphate with standard polyethylene glycol-based lavage solution (Golytely) in the preparation of patients for colonoscopy. Am J Gastroenterol. 1990 Apr;85(4):422-7.

  PMID: 2183591 BACKGROUND

• Frommer D. Cleansing ability and tolerance of three bowel preparations for colonoscopy. Dis Colon Rectum. 1997 Jan;40(1):100-4. doi: 10.1007/BF02055690.

  PMID: 9102248 BACKGROUND

• Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.

  PMID: 7380204 BACKGROUND

MeSH Terms

Interventions

Polyethylene Glycols; Bisacodyl; Ascorbic Acid; MoviPrep

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Robert Enns, MD, FRCP

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 31, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 20, 2016

Record last verified: 2016-06

Locations

CA (1)