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

NCT ID: NCT01865916

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-02-29

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.

Detailed Description

All adults (≥ 19 yrs of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study. Exclusion criteria included those with constipation, suspected or known small bowel obstruction, severe inflammatory bowel disease, and any history of colonic resection. 278 consecutive eligible patients will be randomized to one of two bowel preparations through the use of concealed allocation by a scheduling assistant (blinded) in a one-to-one allocation ratio. Bowel preparations included: (i) 2 L of MoviPrep (2 L PEG 3350 electrolyte solution + ascorbic acid) or (ii) Bi-Peglyte (2 L PEG 3350 electrolyte solution and 15mg bisacodyl). Patients in both arms will be instructed to adhere to a clear liquid diet commensing 24 hours prior to scheduled colonoscopy in addition to their remaining bowel preparation.

The investigators will not have access to the randomization envelopes and the randomized bowel preparation will be stored within the medical record that will not be accessible by the endoscopist. The endoscopists can break blinding and access the bowel prep given when medically necessary.

At the time of their procedure check-in, written consent will be confirmed and patients will respond to a brief survey assessing patient tolerance. All colonoscopies will be performed under conscious sedation by an experienced endoscopist. Endoscopists will be blinded to the bowel preparation until the completion of the study. We will use the Boston Bowel Preparation Scale (BBPS) and Ottawa Bowel Preparation Scale (OBPS) to assess efficacy in bowel preparation.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

2 Liters Bi-Peglyte

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

Group Type: ACTIVE_COMPARATOR

Polyethylene Glycol (PEG) and 15 mg Bisacodyl

Intervention Type: DRUG

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

2 Liters Moviprep

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

Group Type: EXPERIMENTAL

Polyethylene Glycol (PEG) + ascorbic acid

Intervention Type: DRUG

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

Interventions

Polyethylene Glycol (PEG) and 15 mg Bisacodyl

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

Intervention Type: DRUG

Polyethylene Glycol (PEG) + ascorbic acid

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

Intervention Type: DRUG

Other Intervention Names

Bi-Peglyte; Moviprep

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Enns, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

PMID: 4017808 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16763922 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 9744604 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15257632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2183591 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9102248 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7380204 (View on PubMed)

Other Identifiers

H13-00502

Identifier Type: -

Identifier Source: org_study_id