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Completed

NCT Number: NCT02248337

Low Volume Colon Preparation for IBD

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

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Key information

Age range

18 year–85 year

Study type

Interventional

Phase

Phase 4

Primary location

Luigi Sacco University Hospital

Milan, I-20157, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colon preparation for colonoscopy

Drug

Colon cleansing prior to perform colonoscopy

Other names: Colon cleansing

Primary outcomes

  1. Efficacy

    Time frame: During endoscopy within 24 hours after preparation

    Quality of colon cleansing assesse with Ottawa bowel preparation score

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Luigi Sacco University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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