Small Bowel PerforationsSBPNCT05471999
Retrospective Analysis on Small Bowel Perforations
A study testing surgery in people with Small Bowel Perforations, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
A retrospective, monocentric, code-related data analysis of patients with small bowel perforations was performed for the period 2010 to 2019. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Small Bowel Perforations
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 1 Mar 2022
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- small bowel perforation in adults
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Small Bowel Perforations: Etiology, Treatment and Outcome
A retrospective, monocentric, code-related data analysis of patients with small bowel perforations was performed for the period 2010 to 2019.
Read the detailed description
Analyzed parameters were etiology and timing of perforation, associated morbidity and mortality, type of therapy and its success, and long-term consequences for patients, such as the development of short bowel syndrome.
- Conditions
- Small Bowel Perforations
- Being tested
- surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
interventional or surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with SBP | Other | Not described Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
death by SBP
Measured: 30 days
Secondary outcomes (1)
Small bowel syndrome
malabsorption
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jun 2019
- Primary completion15 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel PerforationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective data analysis
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S. Bethge, Prof. Dr., Study chair, Zentrum für klinische Studien der UNiversitätsklinik Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471999
- Sponsor's protocol ID
- 489/2020BO
- Acronym
- SBP
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Methods would be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bowel Perforations: Etiology, Treatment and Outcome
- ClinicalTrials.gov ID
- NCT05471999
- Acronym / sponsor ID
- SBP / 489/2020BO
- Conditions
- Small Bowel Perforations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 25 Jul 2022 (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.
A retrospective, monocentric, code-related data analysis of patients with small bowel perforations was performed for the period 2010 to 2019.
Detailed description
Analyzed parameters were etiology and timing of perforation, associated morbidity and mortality, type of therapy and its success, and long-term consequences for patients, such as the development of short bowel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective data analysis
| Arm | Type | Receives |
|---|---|---|
| Patients with SBP | Other | Procedure: surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- small bowel perforation in adults
Key exclusion criteria (1 listed)
- age < 18 years
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 |
|---|---|---|
| surgeryinterventional or surgical treatment | Procedure or surgery | Patients with SBP |
Primary outcome
mortality rate
Time frame: 30 days
death by SBP
1 secondary outcome
Small bowel syndrome
Time frame: 30 days
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 9 May 2023.
- Individual participant dataSharing planned: Yes. Methods would be shared
Related trials for Small Bowel Perforations
Not yet recruitingObservational study
Upper Gastrointestinal Perforations: a Nationwide Registry-based Study
Acute Abdomen
RecruitingObservational study
Web-based International Register of Emergency Surgery and Trauma
Acute Appendicitis, Acute Cholecystitis
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.
S. Bethge, Prof. Dr. study chair
Zentrum für klinische Studien der UNiversitätsklinik Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Small Bowel Perforations, 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 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 9 May 2023. 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?
mortality rate (time frame: 30 days). 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 9 May 2023.