The Impact of Rockall Risk Scoring System on Management of Upper Gastrointestinal System Bleeding

• Conditions: Gastrointestinal Hemorrhage
• Interventions: Procedure: Gastroscopy

• Registration Number: NCT01269814
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-30
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-16
• Last Update Posted: 2012-10-17
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Go-home group	Gastroscopy	The patients with a Rockall score of 0 or 1 will be prescribed medical therapy, and will be scheduled for elective gastroscopy.

Primary Outcome Measures

Name	Time	Method
The necessity of emergency endoscopy.	1 month

Secondary Outcome Measures

Name	Time	Method
Mortality	1 month
Morbidity	1 month
Length of hospital stay	1 month

Trial Locations

Locations (1)

Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey