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

• ClinicalTrials.gov Identifier: NCT01533090
• Recruitment Status: Completed
• First Posted: February 15, 2012
• Last Update Posted: February 15, 2012
• Sponsor: Catholic University of the Sacred Heart
• Information provided by (Responsible Party): Guido Costamagna, Catholic University of the Sacred Heart

Tracking Information

• First Submitted Date: February 7, 2012
• First Posted Date: February 15, 2012
• Last Update Posted Date: February 15, 2012
• Study Start Date: April 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2012)

Evaluation of the overall quality of bowel preparation [ Time Frame: 4 months ]

Quality of preparation will be graded according to the Ottawa Scale.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 11, 2012)

• safety [ Time Frame: 4 months ]
  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 ]
  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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy
• Official Title: Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

Brief Summary

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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Diagnostic

Condition

• Colonic Polyps
• Cancer Colon
• Inflammatory Bowel Disease

Intervention

• Drug: polyethylene glycol (PEG)
  SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY
• 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

Study Arms

• Active Comparator: polyethylene glycol (PEG)
  Intervention: Drug: polyethylene glycol (PEG)
• Experimental: PEG low volume with bisacodyl
  Intervention: Drug: PEG low volume with bisacodyl

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 11, 2012): 162
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01533090
• Other Study ID Numbers: PMF 105
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Guido Costamagna, Catholic University of the Sacred Heart
• Original Responsible Party: Same as current
• Current Study Sponsor: Catholic University of the Sacred Heart
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Catholic University of the Sacred Heart
• Verification Date: March 2010