Gastrointestinal Hemorrhage, Hematemesis
Conditions
Keywords
Upper gastrointestinal bleeding, Endoscopy, Erythromycin, Gastric lavage
Brief summary
The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.
Detailed description
The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding. One hundred and twenty-two patients admitted within 12 hours after hematemesis will be randomly assigned to receive erythromycin infusion or gastric lavage by nasogastric tube prior to emergency endoscopy. The endoscopic procedures will be recorded on Digital Video Disc (DVD). Two endoscopists blinded to the cleansing strategy will assess the quality of examination of the upper gastrointestinal tract by using scales designed by Frossard and Avgerinos . Secondary endpoints will be the need for a second-look endoscopy, the mean number of blood units transfused, the need of surgery or arteriography, and the mean duration of hospitalization
Interventions
DRUGErythromycin
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
PROCEDUREgastric lavage
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
Sponsors
Ministerio de Sanidad, Servicios Sociales e Igualdad
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* recent hematemesis (\<12 hours)
Exclusion criteria
* macrolides allergy * pregnancy or lactation * treatment with terfenadine, astemizole or cyclosporine * prior gastrectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual quality of endoscopy | The endoscopy will be recorded and subsequently it will be evaluated by two endoscopists unaware of the cleaning strategy. The recording's evaluation will be made within the first 30 days after endoscopy | To assess the visual quality of endoscopy the investigators will use the Avgerinos' score modified by Frossard (Gastroenterology 2002;123:17-23). An score from 0 to 2(0 worst vision, where \< 25% of the surface was visible. 1, 25-75% visible and 2 \>75% visible) was derived from analysis of each area (fundus, body, antrum and bulbus). A score of 6 or greater is considered as a clear stomach, and a score of 5 or lower was considered as a full stomach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| need for arteriography or surgery | within the first 30 days after endoscopy | — |
| number of adverse events as a measure of safety and tolerability | within the first 30 days after endoscopy | — |
| length of endoscopic procedure | within the first 30 days after endoscopy | — |
| need for a second-look endoscopy | within the first 30 days after endoscopy | To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding |
| need of blood transfusion | within 30 days after endoscopy | — |
| length of hospitalisation | within the first 30 days after endoscopy | — |
Countries
Spain
Outcome results
None listed