Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage

March 31, 2015 updated by: Iman Fawzy Montasser, Ain Shams University
This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This present study aimed to evaluate:

Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

1- Technical Design: The technical design included research design, setting, subject and tools for data collection.

Research design:

A descriptive exploratory design was followed to achieve the aim of the study. Study setting: This study was conducted between Tropical department in AinShams university and Gastroenterology and Hepatology department in TheodorBilharz Research Institute.

Sample size: EPI - INFO program version 6 was used for sample size calculation guided by power of the test = 80% - confidence level =95% and accepted margin of error = 5% and risk ratio = 5.5 - total sample minimum accepted = 50 This study included 50 recipients and done Tropical department in Ain Shams university and Gastroenterology and Hepatology department in .

Theodore Bilharz Research Institute

Study Type

Observational

Enrollment (Actual)

50

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

  • Egypt
      • Cairo, Egypt
        • Egypt Ain Shams center University Hospitals

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Egyptian patients with acute upper gastrointestinal bleeding

Description

Inclusion Criteria:

  • Adult Egyptian patients.
  • Patients with acute upper G.I hemorrhage.
  • Informed consent.

Exclusion Criteria:

  • Refuse to participate in this study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Upeer gastrointestinal bleeding
  • Adult Egyptian patients.
  • Patients with acute upper G.I hemorrhage.
  • Informed consent.
Other: Upper gastrointestinal endoscopy
Upper gastrointestinal endoscopy, if stigmata of recent hemorrhage are seen, varices are either injected with ethanolamine or banded, depending on the clinical setting and availability .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical condition of the patients with accute upper gastrointstinal bleeding after 48 hours from endoscopy
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
number of participants with variceal bleeding and other causes of upper gastrointestinal bleeding regarding the clinical condition after 48 hours
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Ain Shams University

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

May 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rockall score

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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