HemorrhageNCT04523753
Endoscopy for Bleeding Situations in Surgical Patients
An observational study of Hemorrhage, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Retrospective analysis of surgical patients with relevant gastrointestinal bleeding situations and indication for endoscopy for bleeding Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- emergency endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 28 Aug 2019
- 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 of the University Hospital of Tübingen Department of General, Visceral and Transplantation Surgery with gastrointestinal bleeding situations were enrolled for this retrospective analysis
Who may be able to join
- Patients of the University Hospital of Tübingen Department of General, Visceral and Transplantation Surgery with gastrointestinal bleeding situations
Who cannot join
- younger patients
- patients without indication for emergency endoscopy for bleeding situations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Endoscopy for Gastrointestinal Bleeding Situations in Surgical Patients
Retrospective analysis of surgical patients with relevant gastrointestinal bleeding situations and indication for endoscopy for bleeding
Read the detailed description
We performed an analysis of all adult, surgial patients with indication for emergency endoscopy because of relevant gastrointestinal bleeding situations. A retrospective analysisof the incidence, causes, endoscopic findings and therapy and the outcome of bleeding situations during a 24-mounths interval in the years 2017, 2018 and 2019 was performed at our tertiary centre. Informed consent was obtained from all participants. Patient records as well as database were analyzed for therapy-specific items.
- Conditions
- Hemorrhage
- Being tested
- emergency endoscopy
- Keywords
- surgical patients, gastrointestinal bleeding
- Medical subject headings
- Hemorrhage, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emergency endoscopyProcedure or surgery
emergency endoscopy for gastrointestinal bleeding situation before or after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
rate identification of bleeding sources
endoscopic reports with identification of bleeding sources
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Jul 2017
- Primary completion31 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523753
- Sponsor's protocol ID
- Olena
- Status last verified
- Jun 2020
- First submitted
- 19 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Endoscopy for Gastrointestinal Bleeding Situations in Surgical Patients
- ClinicalTrials.gov ID
- NCT04523753
- Acronym / sponsor ID
- Olena
- Conditions
- Hemorrhage
- Keywords
- surgical patients, gastrointestinal bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 24 Aug 2020 (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.
Retrospective analysis of surgical patients with relevant gastrointestinal bleeding situations and indication for endoscopy for bleeding
Detailed description
We performed an analysis of all adult, surgial patients with indication for emergency endoscopy because of relevant gastrointestinal bleeding situations. A retrospective analysisof the incidence, causes, endoscopic findings and therapy and the outcome of bleeding situations during a 24-mounths interval in the years 2017, 2018 and 2019 was performed at our tertiary centre. Informed consent was obtained from all participants. Patient records as well as database were analyzed for therapy-specific items.
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
- All patients of the University Hospital of Tübingen Department of General, Visceral and Transplantation Surgery with gastrointestinal bleeding situations were enrolled for this retrospective analysis
Key inclusion criteria (1 listed)
- Patients of the University Hospital of Tübingen Department of General, Visceral and Transplantation Surgery with gastrointestinal bleeding situations
Key exclusion criteria (2 listed)
- younger patients
- patients without indication for emergency endoscopy for bleeding situations
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 |
|---|---|---|
| emergency endoscopyemergency endoscopy for gastrointestinal bleeding situation before or after surgery | Procedure or surgery | – |
Primary outcome
rate identification of bleeding sources
Time frame: 24 months
endoscopic reports with identification of bleeding sources
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 24 Aug 2020.
- Individual participant dataSharing planned: No
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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.
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 Hemorrhage, run by University Hospital Tuebingen at 1 site in Germany.
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 1 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 24 Aug 2020. 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 Germany. 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?
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?
rate identification of bleeding sources (time frame: 24 months). 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 24 Aug 2020.