Colonoscopy Preparation Optimization for INpatients- COIN Study

S

St. Joseph's Healthcare Hamilton

Status and phase

Unknown
Phase 4

Conditions

Bowel Preparation Solutions
Endoscopy

Treatments

Drug: Polyethelene Glycol
Drug: Picosulfate sodium
Drug: Bisacodyl 10mg

Study type

Interventional

Funder types

Other

Identifiers

NCT01627171
RP 12-3657

Details and patient eligibility

About

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.

Enrollment

126 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

126 participants in 3 patient groups

PEG Lyte
Active Comparator group
Description:
PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.
Treatment:
Drug: Polyethelene Glycol
Drug: Bisacodyl 10mg
Pico Salax Split
Experimental group
Description:
Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.
Treatment:
Drug: Picosulfate sodium
Drug: Bisacodyl 10mg
Pico Salax Night Before
Experimental group
Description:
2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy
Treatment:
Drug: Picosulfate sodium
Drug: Bisacodyl 10mg

Trial contacts and locations

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Central trial contact

Lisa Balogh Melanson, BSc

Data sourced from clinicaltrials.gov

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