Clinical trial NCT01269814: The Impact of Rockall Risk Scoring System on Management of Upper Gastrointestinal System Bleeding
Official title: The Impact of Rockall Risk Scoring System on Timing of Endoscopy, Length of Hospital Stay, Morbidity and Mortality in Patients With Upper Gastrointestinal System Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Hemorrhage
Keywords: Gastrointestinal bleeding
Emergency endoscopy
Rockall Risk Scoring System
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients older than 18 years with upper gastrointestinal hemorrhage.

Brief summary: The patients who admit to emergency department with upper gastrointestinal system bleeding will undergo a clinical evaluation with Rockall Risk Scoring System. The patients with Rockall score of 1 or less will be discharged with medical treatment, and will have an elective upper gastrointestinal endoscopy in the end of the 30th day. The impact of Rockall Risk Scoring System on assessing the necessity of emergency endoscopy, length of hospital stay, morbidity, and mortality in low-risk patients will be evaluated.

Detailed description: The patients who admit to emergency department with symptoms of upper gastrointestinal system bleeding will undergo a clinical evaluation. First, diagnosis of upper gastrointestinal system bleeding will be established by combined physical examination and nasogastric tube application. After a certain diagnosis, all of the patients will be scored according to Rockall Risk Scoring System. The patients with a 1 or less Rockall score will have conservative treatment including mucosal protective agent (sucralfat), proton pump inhibitors (omeprazole, lansoprazole, pantoprazole), and hemodynamic monitorization. Should Rockall score and hemodynamic parameters remain unchanged or get improved in the end of 6 hours after admission, oral feeding will be started and the patient will be discharged with anti-ulcer medication (mucosal protective agent and proton pump inhibitor, PO). These patients will be scheduled for upper gastrointestinal endoscopy at 30th day. The patients who have: an initial Rockall score of 2 or greater, an increase in Rockall score or deterioration in hemodynamic parameters during observation, will have emergency endoscopy and will be excluded from the study.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of upper gastrointestinal system bleeding
* Rockall score of 1 or less
* Volunteers
* Agreement with the terms of informed consent

Exclusion Criteria:

* Uncertain clinical diagnosis of upper gastrointestinal system bleeding
* Rockall score of 2 or greater
* Deterioration in hemodynamic parameters during follow-up
* Unwilling patients to join the study
* Disagreement with the terms of informed consent

Primary outcomes:
measure: The necessity of emergency endoscopy.
timeFrame: 1 month
Secondary outcomes:
measure: Morbidity
timeFrame: 1 month
measure: Mortality
timeFrame: 1 month
measure: Length of hospital stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Dr. Sadi Konuk Training and Research Hospital
name: Halil Alis, MD
role: STUDY_DIRECTOR
References: