Duodenum Ulcer PerforationNCT06651008
The New Transition Factors to Surgery of Duodenal Perforation
An observational study of Duodenum Ulcer Perforation, run by Toho University.
Trial summary
In this study,investigators sought to identify new transition factors in the initial evaluation of cases requiring conversion to surgery for duodenal ulcer perforation. This was a retrospective study performed at investigators' hospital between January 2012 and July 2023 with upper gastrointestinal perforation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Duodenum Ulcer Perforation
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective study performed at our hospital between January 2012 and July 2023 with upper gastrointestinal perforation, and included 74 patients admitted to our hospital.
Who may be able to join
- patients of upper gastrointestinal perforation
Who cannot join
- DNR patients
About this study
Official title: The New Factors That Lead to Conversion Surgery in Patients with Duodenal Perforation When Initial Conservative Therapy is Not Completed
In this study,investigators sought to identify new transition factors in the initial evaluation of cases requiring conversion to surgery for duodenal ulcer perforation.
This was a retrospective study performed at investigators' hospital between January 2012 and July 2023 with upper gastrointestinal perforation. 27 patients, who underwent conservative management for the duodenal ulcer perforation, were extracted. Investigators researched the transition rate to surgery and the following factors: 1. Patient background, 2. Time from onset to hospital visit, 3. Vital signs and inflammatory findings on arrival, 4. CT findings of duodenal ulcer perforation and degree / shape of liver coverage for the perforation, and the extent of ascites.
- Conditions
- Duodenum Ulcer Perforation
- Keywords
- conversion to surgery, conservative management,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment completed group | The groupthat completed the conservative treatment for dudenum perforation. | |
| Conversion to surgery group | The group that needed conversion to surgery for duodenum perforation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of conversion to surgery from conservative management for duodenal ulcer perforation.
Th investigators reasearched the transition rate to surgery based on the following factors: 1. Patient background, 2. Time from onset to hospital visit, 3. Vital signs and inflammatory findings on arrival, 4. CT findings of duodenal ulcer perforation and degree / shape of liver coverage for the perforation, and the extent of ascites.
Measured: nearly within 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jan 2012
- Primary completion30 Jul 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenum Ulcer PerforationStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toho University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenjiro Ishii, Toho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651008
- Sponsor's protocol ID
- Toho-retrospective study 1
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Imaging findings etc of study patients will be provided in an anonymous form.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Factors That Lead to Conversion Surgery in Patients with Duodenal Perforation When Initial Conservative Therapy is Not Completed
- ClinicalTrials.gov ID
- NCT06651008
- Acronym / sponsor ID
- Toho-retrospective study 1
- Conditions
- Duodenum Ulcer Perforation
- Keywords
- conversion to surgery, conservative management,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Toho UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 21 Oct 2024 (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.
In this study,investigators sought to identify new transition factors in the initial evaluation of cases requiring conversion to surgery for duodenal ulcer perforation.
This was a retrospective study performed at investigators' hospital between January 2012 and July 2023 with upper gastrointestinal perforation. 27 patients, who underwent conservative management for the duodenal ulcer perforation, were extracted. Investigators researched the transition rate to surgery and the following factors: 1. Patient background, 2. Time from onset to hospital visit, 3. Vital signs and inflammatory findings on arrival, 4. CT findings of duodenal ulcer perforation and degree / shape of liver coverage for the perforation, and the extent of ascites.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment completed group | – | –The groupthat completed the conservative treatment for dudenum perforation. |
| Conversion to surgery group | – | –The group that needed conversion to surgery for duodenum perforation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective study performed at our hospital between January 2012 and July 2023 with upper gastrointestinal perforation, and included 74 patients admitted to our hospital.
Key inclusion criteria (1 listed)
- patients of upper gastrointestinal perforation
Key exclusion criteria (1 listed)
- DNR patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of conversion to surgery from conservative management for duodenal ulcer perforation.
Time frame: nearly within 3days
Th investigators reasearched the transition rate to surgery based on the following factors: 1. Patient background, 2. Time from onset to hospital visit, 3. Vital signs and inflammatory findings on arrival, 4. CT findings of duodenal ulcer perforation and degree / shape of liver coverage for the perforation, and the extent of ascites.
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 21 Oct 2024.
- Individual participant dataSharing planned: Yes. Imaging findings etc of study patients will be provided in an anonymous form.
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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 Duodenum Ulcer Perforation, run by Toho University.
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 1 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 21 Oct 2024. 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 rate of conversion to surgery from conservative management for duodenal ulcer perforation. (time frame: nearly within 3days). 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 21 Oct 2024.