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

October 16, 2012 updated by: Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34147
        • Recruiting
        • Dr. Sadi Konuk Training and Research Hospital
        • Contact:
        • Principal Investigator:
          • Osman Kones, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients older than 18 years with upper gastrointestinal hemorrhage.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The necessity of emergency endoscopy.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: 1 month
1 month
Length of hospital stay
Time Frame: 1 month
1 month
Mortality
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

December 30, 2010

First Submitted That Met QC Criteria

January 3, 2011

First Posted (ESTIMATE)

January 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rockall-GIH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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