Bleeding EsophagealNCT06147115
The Validation of Rockall Scoring System in Predicting Outcomes From Variceal Bleeding
An observational study of Bleeding Esophageal, run by National Center for Gastroentestinal and Liver Disease.
Trial summary
Objective This study aims to evaluate the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients. Design/Method A cross-sectional hospital-based study involved 150 adult Sudanese patients presenting with upper gastrointestinal bleeding (UGIB) of variceal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Esophageal
- What is being tested?
- Assessment tool to determine severity of GI bleeding
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2012to 10 Sep 2012
- 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: A total of 150 patients were enrolled in the study between June and September 2012. The study comprised patients aged 18 years and older, presenting with upper gastrointestinal (GI) bleeding of variceal origin, who visited the outpatient and referral clinic at the center and reported primary complaints of upper GI bleeding (UGIB), including hematemesis and/or melena. Patients with upper GI bleeding resulting from causes other than varices, as well as those who declined to participate in the study, were excluded
Who may be able to join
- aged 18 years and older
- primary complaints of upper GI bleeding
Who cannot join
- Patients with upper GI bleeding resulting from causes other than varices
- who declined to participate in the study
About this study
Official title: The Validation of Rockall Scoring System in Predicting Outcomes From Variceal Bleeding in Sudanese Patients: Cross-sectional Study.
Objective This study aims to evaluate the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients.
Design/Method A cross-sectional hospital-based study involved 150 adult Sudanese patients presenting with upper gastrointestinal bleeding (UGIB) of variceal origin. Patients with UGIB resulting from causes other than varices and those who declined participation were excluded. Data were collected through a structured questionnaire complemented by upper gastrointestinal tract endoscopy findings, and patients were followed up until discharge.
Read more
Results The study encompassed 150 patients, predominantly male (117, 78%), aged between 18 and 60 years (n=119, 79%), residing mainly in central regions (134, 89%). The leading presenting complaints included hematemesis (70, 46.7%) and melena (22, 14.6%). Notably, peri-portal fibrosis (101, 67.3%) and cirrhosis (24, 16%) were the primary etiological factors, with a significant prevalence of alcohol consumption (87, 58%). Concerning the grade of esophageal varices, grades III and IV were most prevalent (67, 44.7% and 47, 31.3%, respectively), and fundal varices were identified in 13 patients (8.7%). The mean Rockall score was 3.83 ± 1.99, indicating moderate severity. Additionally, the Rockall score showed significant associations with the number of sessions, complications, bleeding recurrence, duration of hospital stay, and mortality (p < 0.05).
Conclusion Understanding the significance of the Rockall scoring system and its applicability to Sudanese patients with variceal bleeding has the potential to guide more effective strategies in the management of upper gastrointestinal tract bleeding, ultimately improving patient outcomes and reducing morbidity and mortality.
- Conditions
- Bleeding Esophageal
- Being tested
- Assessment tool to determine severity of GI bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment tool to determine severity of GI bleedingOther
The Rockall score is a validated mortality risk assessment for patients admitted with upper GI bleeding.
What is being measured
The primary outcome is the main question the study is designed to answer.
the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients
The primary outcome measure in this study appears to be the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients presenting to the Mohammed Salih Idris Bleeding Center (MSIBC). The study aims to assess the effectiveness of the Rockall scoring system in predicting mortality, bleeding recurrence, and other clinical outcomes in Sudanese patients with variceal bleeding. The Rockall scoring system incorporates various factors, including age, evidence of shock, coexisting medical conditions, and the presence of visible signs of hemorrhage. The study investigates the association between Rockall scores and clinical outcomes such as mortality, bleeding recurrence, complications, duration of hospital stay, and interventions conducted. The validation of the Rockall scoring system in the context of variceal bleeding in Sudan is crucial for risk stratification and guiding the management of patients with variceal bleeding.
Measured: June 2012 - Sep 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Jun 2012
- Primary completion1 Sep 2012
- Study completion10 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding EsophagealStudies 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
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Gastroentestinal and Liver Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147115
- Sponsor's protocol ID
- GastroentestinalLiverRockall
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of Rockall Scoring System in Predicting Outcomes From Variceal Bleeding in Sudanese Patients: Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT06147115
- Acronym / sponsor ID
- GastroentestinalLiverRockall
- Conditions
- Bleeding Esophageal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Center for Gastroentestinal and Liver DiseaseUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Sep 2012 (actual)
- Study completion
- 10 Sep 2012 (actual)
- First posted
- 27 Nov 2023 (actual)
- 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.
Objective This study aims to evaluate the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients.
Design/Method A cross-sectional hospital-based study involved 150 adult Sudanese patients presenting with upper gastrointestinal bleeding (UGIB) of variceal origin. Patients with UGIB resulting from causes other than varices and those who declined participation were excluded. Data were collected through a structured questionnaire complemented by upper gastrointestinal tract endoscopy findings, and patients were followed up until discharge.
Results The study encompassed 150 patients, predominantly male (117, 78%), aged between 18 and 60 years (n=119, 79%), residing mainly in central regions (134, 89%). The leading presenting complaints included hematemesis (70, 46.7%) and melena (22, 14.6%). Notably, peri-portal fibrosis (101, 67.3%) and cirrhosis (24, 16%) were the primary etiological factors, with a significant prevalence of alcohol consumption (87, 58%). Concerning the grade of esophageal varices, grades III and IV were most prevalent (67, 44.7% and 47, 31.3%, respectively), and fundal varices were identified in 13 patients (8.7%). The mean Rockall score was 3.83 ± 1.99, indicating moderate severity. Additionally, the Rockall score showed significant associations with the number of sessions, complications, bleeding recurrence, duration of hospital stay, and mortality (p < 0.05).
Conclusion Understanding the significance of the Rockall scoring system and its applicability to Sudanese patients with variceal bleeding has the potential to guide more effective strategies in the management of upper gastrointestinal tract bleeding, ultimately improving patient outcomes and reducing morbidity and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 patients were enrolled in the study between June and September 2012. The study comprised patients aged 18 years and older, presenting with upper gastrointestinal (GI) bleeding of variceal origin, who visited the outpatient and referral clinic at the center and reported primary complaints of upper GI bleeding (UGIB), including hematemesis and/or melena. Patients with upper GI bleeding resulting from causes other than varices, as well as those who declined to participate in the study, were excluded
Key inclusion criteria (2 listed)
- aged 18 years and older
- primary complaints of upper GI bleeding
Key exclusion criteria (2 listed)
- Patients with upper GI bleeding resulting from causes other than varices
- who declined to participate in the study
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 |
|---|---|---|
| Assessment tool to determine severity of GI bleedingThe Rockall score is a validated mortality risk assessment for patients admitted with upper GI bleeding. | Other | – |
Primary outcome
the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients
Time frame: June 2012 - Sep 2012
The primary outcome measure in this study appears to be the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients presenting to the Mohammed Salih Idris Bleeding Center (MSIBC). The study aims to assess the effectiveness of the Rockall scoring system in predicting mortality, bleeding recurrence, and other clinical outcomes in Sudanese patients with variceal bleeding. The Rockall scoring system incorporates various factors, including age, evidence of shock, coexisting medical conditions, and the presence of visible signs of hemorrhage. The study investigates the association between Rockall scores and clinical outcomes such as mortality, bleeding recurrence, complications, duration of hospital stay, and interventions conducted. The validation of the Rockall scoring system in the context of variceal bleeding in Sudan is crucial for risk stratification and guiding the management of patients with variceal bleeding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding Esophageal, run by National Center for Gastroentestinal and Liver Disease.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients (time frame: June 2012 - Sep 2012). 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 27 Nov 2023.