Clinical trial

Lower Gastrointestinal Bleeding in the Emergency Department: High-Volume Vs Low-Volume Peg Bowel Preparation for Colonoscopy

Name
20192668
Description
The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS). The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.
Trial arms
Trial start
2019-11-01
Estimated PCD
2021-05-30
Trial end
2021-06-30
Status
Completed
Treatment
Low volume macrogol
Clensia 2 lt
Arms:
Low-Volume
High volume macrogol
Selg 4 lt
Arms:
High-Volume
Size
228
Primary endpoint
intestinal cleansing
during colonscopy procedure
Eligibility criteria
Inclusion Criteria: * males or females * \> 18 years and \<85 years, * hemodynamically stable, * able to sign informed consent * requiring colonoscopy * anemia (loss of at least 2 g/dl of Hb) with or without active bleeding Exclusion Criteria: * suspected or confirmed pregnancy, * hemodynamically unstable patients, * patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation, * toxic megacolon, * major colonic resection, * heart failure (Class III or IV NYHA), * severe liver failure, * end-stage renal disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 228, 'type': 'ACTUAL'}}
Updated at
2023-04-04

1 organization

2 products

1 indication

Product
Macrogol