A Phase 3 interventional study of Erythromycin and gastric lavage in Gastrointestinal Hemorrhage and Hematemesis, sponsored by Hospital Universitari de Bellvitge. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-08.
Sponsored by Hospital Universitari de Bellvitge · Phase 3, Interventional, and Treatment
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.
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
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 122 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
Procedure: gastric lavage
administration of 250mgr of erythromycin before the endoscopy
Drug: Erythromycin
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
Also known as: Pantomicina Intravenosa
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
Visual quality of 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.
Time frame: 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
need for a second-look endoscopy
To assess the need of a second-look endoscopy due to a full stomach during the first endoscopy or due to rebleeding
Time frame: within the first 30 days after endoscopy
need of blood transfusion
Time frame: within 30 days after endoscopy
number of adverse events as a measure of safety and tolerability
Time frame: within the first 30 days after endoscopy
length of hospitalisation
Time frame: within the first 30 days after endoscopy
length of endoscopic procedure
Time frame: within the first 30 days after endoscopy
need for arteriography or surgery
Time frame: within the first 30 days after endoscopy
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Hospital Universitari de Bellvitge