Low Volume Colon Preparation for IBD

Luigi Sacco University Hospital

Status and phase

Completed

Phase 4

Conditions

Inflammatory Bowel Disease

Treatments

Drug: Colon preparation for colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02248337

LOVOL-IBD

Details and patient eligibility

About

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

Full 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

Enrollment

216 patients

Sex

Ages

18 to 85 years old

Volunteers

No 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