Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy (LowVolumePEG)
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Purpose
The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability.
LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.
| Condition | Intervention |
|---|---|
|
Colonic Polyps Cancer Colon Inflammatory Bowel Disease |
Drug: polyethylene glycol (PEG) Drug: PEG low volume with bisacodyl |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
| Official Title: | Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy |
- Evaluation of the overall quality of bowel preparation [ Time Frame: 4 months ] [ Designated as safety issue: No ]Quality of preparation will be graded according to the Ottawa Scale.
- safety [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]incidence and severity of the following GI unexpected adverse events: nausea, abdominal bloating, abdominal pain/cramps on a 5-point Likert scale
- compliance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Proportion of patients able to:
- drink < 75% of the solution (poor compliance)
- drink at least 75% of the solution (good compliance)
- drink all the solution (optimal compliance)
| Enrollment: | 162 |
| Study Start Date: | April 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: polyethylene glycol (PEG) |
Drug: polyethylene glycol (PEG)
SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY
|
| Experimental: PEG low volume with bisacodyl |
Drug: PEG low volume with bisacodyl
Lovolesse + Lovoldyl 2L of Lovolesse with 2 or 3 tablets of bisacodyl the day before of colonoscopy or 2L of Lovolesse with 2 or 3 tablets of bisacodyl the same day of colonoscopy
|
Detailed Description:
A polyethylene glycol (PEG) electrolyte lavage solution (PEG-ELS) was originally developed in 1980 by the Fordtran group as isosmotic preparation for minimal water and electrolyte exchange with plasma to ensure safe cleansing of the bowel through a mechanical effect of large-volume lavage. The conventional total dose of 4 L given the day before the procedure is safe and effective and has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG-ELS have been shown to provide adequate colon cleansing and better tolerability.
In the last recent years, time of preparation has been demonstrated to be a critical factor for bowel preparation for colonoscopy. Several studies have demonstrated that reducing the time interval between the completion of bowel preparation and the exam improves colon cleansing compared with standard dose regimen of the PEG-electrolyte solution given the day before colonoscopy. At the same time manufacturers have tried to improve the taste and palatability of PEG formulations by adding suitable ingredients such as ascorbic acid or citric acid. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.
The results of this study will tells us if the last-hour preparation is effective and offers adequate tolerability and compliance to be adopted in clinical practice.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- both sexes
- aged between 18 and 85 yr
- undergoing a complete colonoscopy
Exclusion Criteria:
- known or suspected gastrointestinal obstruction or perforation
- toxic megacolon
- major colonic resection
- pregnant or at risk of becoming pregnant women
- lactating women
- inability to comprehend the full nature and purpose of the study
- no signed informed consent prior to inclusion in the study
- known or suspected hypersensitivity to the active principles or other ingredients
- history of anaphylaxis to drugs or allergic reactions in general
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Guido Costamagna, Professor, Catholic University of the Sacred Heart |
| ClinicalTrials.gov Identifier: | NCT01533090 History of Changes |
| Other Study ID Numbers: | PMF 105 |
| Study First Received: | February 7, 2012 |
| Last Updated: | February 11, 2012 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Colonic Polyps Inflammatory Bowel Diseases Intestinal Diseases Intestinal Polyps Polyps Pathological Conditions, Anatomical Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Bisacodyl Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013