Recruiting

Pico-Salax vs. PEG-Lyte

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT01627171

Conditions

Endoscopy

Bowel Preparation Solutions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bisacodyl 10mg

Polyethelene Glycol

Picosulfate sodium

Study Details

Brief summary:

Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.

Conditions

Endoscopy

Bowel Preparation Solutions

Study ID

NCT01627171

Start date

Sep, 2012

Status verified date

Jan, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inpatient colonoscopy
  • Age greater than 18 years old
  • Able to give consent

Exclusion Criteria:

  • No consent obtained
  • Pregnancy or lactating
  • Renal impairment
  • Severe CHF (NYHA class 3/4)
  • Recent myocardial infarction (preceding 6 months)
  • Ileus
  • Ascites
  • Severe Colitis
  • Toxic Megacolon
  • Gastrointestinal Obstruction
  • PEG tube
  • Previous large bowel resection
  • Allergy to study drug

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PEG Lyte

PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.

experimental: Pico Salax Split

Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.

experimental: Pico Salax Night Before

2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy

Interventions

Bisacodyl 10mg

Given at the start of the bowel preparation the day before colonoscopy

Polyethelene Glycol

280g reconstituted in 4 liters of water

Picosulfate sodium

Two sachets, Each sachet has 10mg dose

Primary outcome measure

  • Ottawa Bowel Prep Score [ Time Frame: 30 minutes after procedure ]

Central Contacts and Locations

Central contacts

Lisa Balogh Melanson, BSc

905-522-1155lbalogh@stjosham.on.ca

Locations

St Joseph Hospital

Recruiting

Hamilton, Ontario, Canada, L8N4A6

Contacts

Lisa Balogh-Melanson, BSc

905-522-1155lbalogh@stjosham.on.ca

Principal Investigator:

Khurram J Khan, MD,BSc

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Jan 30, 2013

Last verified

Jan, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2013-01-30.