GastroIntestinal Bleeding
Conditions
Brief summary
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.
Interventions
DRUGLow volume macrogol
Clensia 2 lt
DRUGHigh volume macrogol
Selg 4 lt
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intestinal cleansing | during colonscopy procedure | Using Boston Bowel Preparation Scale score (from 0 to 9, where 9 is worst preparation level) |
Countries
Italy
Outcome results
None listed