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Low Volume Colon Preparation for IBD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248337
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Gianpiero Manes, Luigi Sacco University Hospital

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

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Drug: Colon preparation for colonoscopy Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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 Name: 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 Name: Colon cleansing




Primary Outcome Measures :
  1. Efficacy [ Time Frame: During endoscopy within 24 hours after preparation ]
    Quality of colon cleansing assesse with Ottawa bowel preparation score


Secondary Outcome Measures :
  1. Compliance [ Time Frame: during product assumption ]
    Intake of at least 75% of the product volume

  2. Tollerability [ Time Frame: during product assumption ]
    Occurrence of discomfort during drug intake

  3. safety [ Time Frame: From drug intake to the end of colonoscopy ]
    Occurrence of side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248337


Locations
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Italy
Luigi Sacco University Hospital
Milano, Italy, I-20157
Sponsors and Collaborators
Luigi Sacco University Hospital
Investigators
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Study Chair: gianpiero manes, MD AO G. Salvini Garbagnate Milanes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gianpiero Manes, MD, Luigi Sacco University Hospital
ClinicalTrials.gov Identifier: NCT02248337    
Other Study ID Numbers: LOVOL-IBD
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Gianpiero Manes, Luigi Sacco University Hospital:
Colon preparation; Colonoscopy; Inflammatory bowel disease
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis