Diseases or ConditionsPUDNCT06421064
Clinical Profile and Outcome of Perforated PUD
An observational study of Diseases or Conditions, run by Badhaasaa at 1 site in Ethiopia.
Trial summary
Perforated peptic ulcer disease (PPUD) is series illness that need emergency intervention. Its overall clinical profile and treatment outcome was also not well studied in developing countries. Therefore the study was aimed to see the outcome of surgical intervention and associated factors. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diseases or Conditions
- What is being tested?
- Perforation repair
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All surgical emergency admissions.
Who may be able to join
- All adults with a diagnosis of perforated PUD managed at HU until discharged
Who cannot join
- Patients who were referred to other institutions before official discharge, Incomplete Medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Profile and Surgical Treatment Outcome of Perforated Peptic Ulcer Disease in Public Hospitals of Eastern Ethiopia: a Prospective Multicenter Study.
Perforated peptic ulcer disease (PPUD) is series illness that need emergency intervention. Its overall clinical profile and treatment outcome was also not well studied in developing countries. Therefore the study was aimed to see the outcome of surgical intervention and associated factors.
The study was a retrospective observational study conducted using the medical records of patients operated on for perforated peptic ulcer disease at a multicenter, in eastern Ethiopia.
Read the detailed description
This study was designed to investigate the clinical characteristics and treatment outcomes among adult patients presented to the study areas. Three teaching Hospitals and one Regional Hospital were chosen and data collection was effected for two years. One hundred seventy patients participated in this observational study.
- Conditions
- Diseases or Conditions
- Being tested
- Perforation repair
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perforation repairProcedure or surgery
All patients were operated with slight difference but all had perforation repaired.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival outcome of perforated PUD
This is a dichotomous variable, either survived or deceased.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases or ConditionsStudies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badhaasaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Badhaasaa, Haramaya Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421064
- Sponsor's protocol ID
- HURG-2020
- Acronym
- PUD
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Owned by the university
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Profile and Surgical Treatment Outcome of Perforated Peptic Ulcer Disease in Public Hospitals of Eastern Ethiopia: a Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT06421064
- Acronym / sponsor ID
- PUD / HURG-2020
- Conditions
- Diseases or Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- BadhaasaaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 May 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.
Perforated peptic ulcer disease (PPUD) is series illness that need emergency intervention. Its overall clinical profile and treatment outcome was also not well studied in developing countries. Therefore the study was aimed to see the outcome of surgical intervention and associated factors.
The study was a retrospective observational study conducted using the medical records of patients operated on for perforated peptic ulcer disease at a multicenter, in eastern Ethiopia.
Detailed description
This study was designed to investigate the clinical characteristics and treatment outcomes among adult patients presented to the study areas. Three teaching Hospitals and one Regional Hospital were chosen and data collection was effected for two years. One hundred seventy patients participated in this observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All surgical emergency admissions.
Key inclusion criteria (1 listed)
- All adults with a diagnosis of perforated PUD managed at HU until discharged
Key exclusion criteria (1 listed)
- Patients who were referred to other institutions before official discharge, Incomplete Medical record
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 |
|---|---|---|
| Perforation repairAll patients were operated with slight difference but all had perforation repaired. | Procedure or surgery | – |
Primary outcome
Survival outcome of perforated PUD
Time frame: 2 years
This is a dichotomous variable, either survived or deceased.
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 May 2024.
- Individual participant dataSharing planned: No. Owned by the university
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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 Diseases or Conditions, run by Badhaasaa at 1 site in Ethiopia.
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 May 2024. 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 Ethiopia. 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?
Survival outcome of perforated PUD (time frame: 2 years). 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 May 2024.