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Low Volume Colon Preparation for IBD

Primary Purpose

Inflammatory Bowel Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Colon preparation for colonoscopy
Sponsored by
Luigi Sacco University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Colon preparation; Colonoscopy; Inflammatory bowel disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

  • Luigi Sacco University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

4 Liter PEG

2 Liter PEG plus bisacodil

Arm Description

Colon preparation for colonoscopy: PEG 4 Liter before endoscopy

Colon preparation for colonoscopy: PEG 2 L before endoscopy

Outcomes

Primary Outcome Measures

Efficacy
Quality of colon cleansing assesse with Ottawa bowel preparation score

Secondary Outcome Measures

Compliance
Intake of at least 75% of the product volume
Tollerability
Occurrence of discomfort during drug intake
safety
Occurrence of side effects

Full Information

First Posted
September 20, 2014
Last Updated
September 23, 2014
Sponsor
Luigi Sacco University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02248337
Brief Title
Low Volume Colon Preparation for IBD
Official Title
Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luigi Sacco University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Colon preparation; Colonoscopy; Inflammatory bowel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 Liter PEG
Arm Type
Active Comparator
Arm Description
Colon preparation for colonoscopy: PEG 4 Liter before endoscopy
Arm Title
2 Liter PEG plus bisacodil
Arm Type
Experimental
Arm Description
Colon preparation for colonoscopy: PEG 2 L before endoscopy
Intervention Type
Drug
Intervention Name(s)
Colon preparation for colonoscopy
Other Intervention Name(s)
Colon cleansing
Intervention Description
Colon cleansing prior to perform colonoscopy
Primary Outcome Measure Information:
Title
Efficacy
Description
Quality of colon cleansing assesse with Ottawa bowel preparation score
Time Frame
During endoscopy within 24 hours after preparation
Secondary Outcome Measure Information:
Title
Compliance
Description
Intake of at least 75% of the product volume
Time Frame
during product assumption
Title
Tollerability
Description
Occurrence of discomfort during drug intake
Time Frame
during product assumption
Title
safety
Description
Occurrence of side effects
Time Frame
From drug intake to the end of colonoscopy

10. Eligibility

Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gianpiero manes, MD
Organizational Affiliation
AO G. Salvini Garbagnate Milanes
Official's Role
Study Chair
Facility Information:
Facility Name
Luigi Sacco University Hospital
City
Milano
ZIP/Postal Code
I-20157
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26164666
Citation
Manes G, Fontana P, de Nucci G, Radaelli F, Hassan C, Ardizzone S. Colon Cleansing for Colonoscopy in Patients with Ulcerative Colitis: Efficacy and Acceptability of a 2-L PEG Plus Bisacodyl Versus 4-L PEG. Inflamm Bowel Dis. 2015 Sep;21(9):2137-44. doi: 10.1097/MIB.0000000000000463.
Results Reference
derived

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Low Volume Colon Preparation for IBD

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