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

Gastrointestinal Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01269814
• Other study ID #: Rockall-GIH
• Status: Recruiting
• Phase: Phase 4
• First received: December 30, 2010
• Last updated: October 16, 2012
• Start date: December 2010
• Est. completion date: March 2013

Study information

• Verified date: October 2012
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: Osman Kones, MD
• Phone: 090-542-36968282
• Email: osman.kones[@]beah.gov.tr
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

Procedure:
• Gastroscopy
Gastroscopy

Locations

Country	Name	City	State
Turkey	Dr. Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The necessity of emergency endoscopy.		1 month	No
Secondary	Morbidity		1 month	No
Secondary	Mortality		1 month	No
Secondary	Length of hospital stay		1 month	No