Gastrointestinal HemorrhageNCT01269814
The Impact of Rockall Risk Scoring System on Management of Upper Gastrointestinal System Bleeding
An observational study of Gastrointestinal Hemorrhage, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Gastroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients older than 18 years with upper gastrointestinal hemorrhage.
Who may be able to join
- Clinical diagnosis of upper gastrointestinal system bleeding
- Rockall score of 1 or less
- Volunteers
- Agreement with the terms of informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34147
Halil Alis, MD, 090-505-2327425, halilalis@yahoo.com
Osman Kones, MD
About this study
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
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.
Read the 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.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Gastroscopy
- Keywords
- Gastrointestinal bleeding, Emergency endoscopy, Rockall Risk Scoring System
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroscopyProcedure or surgery
Gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The necessity of emergency endoscopy.
Measured: 1 month
Secondary outcomes (3)
Morbidity
Measured: 1 month
Mortality
Measured: 1 month
Length of hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Halil Alis, MD, Study director, Dr. Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269814
- Sponsor's protocol ID
- Rockall-GIH
- Status last verified
- Oct 2012
- First submitted
- 30 Dec 2010
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01269814
- Acronym / sponsor ID
- Rockall-GIH
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- Gastrointestinal bleeding, Emergency endoscopy, Rockall Risk Scoring System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Go-home group | – | Procedure: GastroscopyThe patients with a Rockall score of 0 or 1 will be prescribed medical therapy, and will be scheduled for elective gastroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 18 years with upper gastrointestinal hemorrhage.
Key inclusion criteria (4 listed)
- Clinical diagnosis of upper gastrointestinal system bleeding
- Rockall score of 1 or less
- Volunteers
- Agreement with the terms of informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastroscopyGastroscopy | Procedure or surgery | Go-home group |
Primary outcome
The necessity of emergency endoscopy.
Time frame: 1 month
3 secondary outcomes
Morbidity
Time frame: 1 month
Mortality
Time frame: 1 month
Length of hospital stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halil Alis, MD study director
Dr. Sadi Konuk Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Hemorrhage, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osman Kones, MD (090-542-36968282, osman.kones@beah.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The necessity of emergency endoscopy. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.