Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy (LowVolumePEG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guido Costamagna, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01533090
First received: February 7, 2012
Last updated: February 11, 2012
Last verified: March 2010
  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

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533090

Locations
Italy
Digestive Endoscopy Unit of Catholic University
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
  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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Polyps
Pathological Conditions, Anatomical
Polyps
Bisacodyl
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014