Prospective Assessment of the Rockall Risk ScoringSystem... | NCT02405286

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

NCT02405286

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Apr 1, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Gastrointestinal Bleeding

Interventions

Upper gastrointestinal endoscopy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 24, 2015

First Submission Date that Met QC Criteria

Mar 31, 2015

First Posted Date

Apr 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2015

Last Update Posted Date

Apr 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Iman Fawzy Montasser, Lecturer of tropical medicine , Ain Shams university, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Upeer gastrointestinal bleeding		Adult Egyptian patients. Patients with acute upper G.I hemorrhage. Informed consent.	Other: Upper gastrointestinal endoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Upper gastrointestinal endoscopy	Other	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 .

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Refuse to participate in this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Adult Egyptian patients with acute upper gastrointestinal bleeding

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Egypt Ain Shams center University Hospitals		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006471	Gastrointestinal Hemorrhage

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016145	Endoscopy, Digestive System

Ancestor Terms

ID	Term
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided