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

Inflammatory Bowel Disease Clinical Trial

— LowVolumePEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533090
• Other study ID #: PMF 105
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: February 11, 2012
• Start date: April 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2010
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer Colon
• Colonic Polyps
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	Digestive Endoscopy Unit of Catholic University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the overall quality of bowel preparation	Quality of preparation will be graded according to the Ottawa Scale.	4 months	No
Secondary	safety	incidence and severity of the following GI unexpected adverse events: nausea, abdominal bloating, abdominal pain/cramps on a 5-point Likert scale	4 months	Yes
Secondary	compliance	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)	4 months	No