Colonoscopy Preparation Optimization for INpatients- COIN Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endoscopy Bowel Preparation Solutions |
Drug: Bisacodyl 10mg Drug: Polyethelene Glycol Drug: Picosulfate sodium |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients |
- Ottawa Bowel Prep Score [ Time Frame: 30 minutes after procedure ] [ Designated as safety issue: No ]Using a standardized, validated score for measuring quality of bowel preparation
- Procedures Cancelled or repeated due to inadequate bowel preparation [ Time Frame: During admission (average of 2 weeks) ] [ Designated as safety issue: No ]If bowel preparation is deemed inadequate to the point the procedure must be cancelled or rescheduled
- Individual Components of Ottawa Bowel Prep Score [ Time Frame: 30 minutes after procedure ] [ Designated as safety issue: No ]Each section of prep score evaluating the right, mid, and left colon, as well as the fluid score will be analyzed individually
- Adverse Effects [ Time Frame: Up to 48 hours after procedure ] [ Designated as safety issue: Yes ]Any adverse effects that may be attributed to the intervention
- Tolerability of the preparation [ Time Frame: Within 1 day of intervention ] [ Designated as safety issue: No ]A questionnaire to assess the overall tolerability of the preparation.
| Estimated Enrollment: | 126 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PEG Lyte
PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.
|
Drug: Bisacodyl 10mg
Given at the start of the bowel preparation the day before colonoscopy
Drug: Polyethelene Glycol
280g reconstituted in 4 liters of water
Other Name: PEG-Lyte
|
|
Experimental: Pico Salax Split
Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.
|
Drug: Bisacodyl 10mg
Given at the start of the bowel preparation the day before colonoscopy
Drug: Picosulfate sodium
Two sachets, Each sachet has 10mg dose
Other Name: Pico-Salax
|
|
Experimental: Pico Salax Night Before
2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy
|
Drug: Bisacodyl 10mg
Given at the start of the bowel preparation the day before colonoscopy
Drug: Picosulfate sodium
Two sachets, Each sachet has 10mg dose
Other Name: Pico-Salax
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lisa Balogh Melanson, BSc | 905-522-1155 ext 33673 | lbalogh@stjosham.on.ca |
| Canada, Ontario | |
| St Joseph Hospital | Recruiting |
| Hamilton, Ontario, Canada, L8N4A6 | |
| Contact: Lisa Balogh-Melanson, BSc 905-522-1155 ext 33673 lbalogh@stjosham.on.ca | |
| Principal Investigator: Khurram J Khan, MD,BSc | |
| Sub-Investigator: David Morgan, MD, MSc | |
| Sub-Investigator: Robert Spaziani, MD | |
| Sub-Investigator: Subhas Ganguli, MD, MSc | |
| Sub-Investigator: Keith Tsoi, MD | |
| Sub-Investigator: Subash Jalali, MBBS | |
| Sub-Investigator: Houssein Fergani, MD | |
| Sub-Investigator: Abbas Merali, MD | |
| Sub-Investigator: Nauzer Forbes, MD | |
| Principal Investigator: | Khurram J Khan, MD, BSc | St Josephs |
More Information
No publications provided
| Responsible Party: | Khurram Khan, Assistant Professor of Medicine, St. Joseph's Healthcare Hamilton |
| ClinicalTrials.gov Identifier: | NCT01627171 History of Changes |
| Other Study ID Numbers: | RP 12-3657 |
| Study First Received: | June 19, 2012 |
| Last Updated: | January 28, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Bisacodyl Picosulfate sodium Cathartics |
Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013