The Focus of Study is to Elucidate Which Are the Factors Requiring the Duodenostomy and Which Postoperative Course is for These PatientsNCT05359029
Duodenostomy to Treat Duodenal Perforation
An observational study of The Focus of Study is to Elucidate Which Are the Factors Requiring the Duodenostomy and Which Postoperative Course is for These Patients, run by University of Foggia at 1 site in Italy.
Trial summary
In this study the investigators focused on duodenal perforations, requiring a tube duodenostomy and have analyzed the main features, that have influenced the surgical choices. Five patients were enrolled. Read more about this study
- Who is it for?
- Ages Up to 89 years
- Conditions the study is for
- The Focus of Study is to Elucidate Which Are the Factors Requiring the Duodenostomy and Which Postoperative Course is for These Patients
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 31 Dec 2020
- 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 Up to 89 years
- All sexes
- Child, Adult, Older adult
Study population: In 2 cases a tube duodenostomy was executed, due to excessive size of perforation and extreme presence of intra-abdominal infections. In addition, other cases of duodenal injury due to other causes were treated, 3 of these requiring a tube duodenostomy approach.
Who may be able to join
- excessive size of perforation
- extreme presence of intra-abdominal infections.
Who cannot join
- patients treated by medical therapy, endoscopic techniques, o surgical approaches
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duodenostomy on Foley and Gastroenteroanastomosis: Treatment of Second Duodenal Part Perforation.
In this study the investigators focused on duodenal perforations, requiring a tube duodenostomy and have analyzed the main features, that have influenced the surgical choices. Five patients were enrolled. Most of duodenal perforations can successfully be managed by simple repair, while complicated procedures are needed for complex injuries. Tube duodenostomy is a damage control procedure, for large duodenal perforations when further repair techniques are not recommended due to the duodenal damage, hemodynamic instability of the patient or the absence of surgical expertise for complex reconstruction.
- Keywords
- Duodenostomy, duodenal perforation, emergency surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Death of patient
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Sep 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus of Study is to Elucidate Which Are the Factors Requiring the Duodenostomy and Which Postoperative Course is for These PatientsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pacilli, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359029
- Sponsor's protocol ID
- UFoggia
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duodenostomy on Foley and Gastroenteroanastomosis: Treatment of Second Duodenal Part Perforation.
- ClinicalTrials.gov ID
- NCT05359029
- Acronym / sponsor ID
- UFoggia
- Keywords
- Duodenostomy, duodenal perforation, emergency surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 May 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.
In this study the investigators focused on duodenal perforations, requiring a tube duodenostomy and have analyzed the main features, that have influenced the surgical choices. Five patients were enrolled. Most of duodenal perforations can successfully be managed by simple repair, while complicated procedures are needed for complex injuries. Tube duodenostomy is a damage control procedure, for large duodenal perforations when further repair techniques are not recommended due to the duodenal damage, hemodynamic instability of the patient or the absence of surgical expertise for complex reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 89 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- In 2 cases a tube duodenostomy was executed, due to excessive size of perforation and extreme presence of intra-abdominal infections. In addition, other cases of duodenal injury due to other causes were treated, 3 of these requiring a tube duodenostomy approach.
Key inclusion criteria (2 listed)
- excessive size of perforation
- extreme presence of intra-abdominal infections.
Key exclusion criteria (1 listed)
- patients treated by medical therapy, endoscopic techniques, o surgical approaches
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
Death of patient
Time frame: 4 months
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 12 May 2022.
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 The Focus of Study is to Elucidate Which Are the Factors Requiring the Duodenostomy and Which Postoperative Course is for These Patients, run by University of Foggia at 1 site in Italy.
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 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 12 May 2022. 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 Italy. 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?
Death of patient (time frame: 4 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 12 May 2022.