Low Volume Colon Preparation for IBD

September 23, 2014 updated by: Gianpiero Manes, Luigi Sacco University Hospital

Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil

Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low-volume preparations are gaining attention for higher acceptability. This study compares efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution in patients with inflammatory bowel disease-related colitis.

This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient acceptance, satisfaction, and related symptoms will be also recorded. The study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, I-20157
        • Luigi Sacco University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-Adult outpatiets with IBD colitis undergoing colonoscopy

Exclusion Criteria:

  • Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency
  • Pregnant or breastfeeding women were also excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4 Liter PEG
Colon preparation for colonoscopy: PEG 4 Liter before endoscopy
Drug: Colon preparation for colonoscopy
Colon cleansing prior to perform colonoscopy
Other Names:
  • Colon cleansing
Experimental: 2 Liter PEG plus bisacodil
Colon preparation for colonoscopy: PEG 2 L before endoscopy
Drug: Colon preparation for colonoscopy
Colon cleansing prior to perform colonoscopy
Other Names:
  • Colon cleansing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: During endoscopy within 24 hours after preparation
Quality of colon cleansing assesse with Ottawa bowel preparation score
During endoscopy within 24 hours after preparation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: during product assumption
Intake of at least 75% of the product volume
during product assumption
Tollerability
Time Frame: during product assumption
Occurrence of discomfort during drug intake
during product assumption
safety
Time Frame: From drug intake to the end of colonoscopy
Occurrence of side effects
From drug intake to the end of colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luigi Sacco University Hospital

Investigators

  • Study Chair: gianpiero manes, MD, AO G. Salvini Garbagnate Milanes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 20, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOVOL-IBD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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