Peptic Ulcer PerforationNCT05489497
Morbidity After Surgical Treatment of Perforated Ulcer
An observational study of Peptic Ulcer Perforation, run by University of Monastir.
Trial summary
The main objective of our study is to identify the risk factors for postoperative morbidity after surgical treatment of Perforated peptic ulcer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Perforation
- What is being tested?
- Primary closure with or without omental grafting
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jun 2021
- 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: patient who presented to tahar sfar hospital for perforated ulcer
Who may be able to join
- patients who underwent surgery for a perforated peptic ulcer in the General Surgery Department of Taher Sfar University Hospital in Mahdia, between January 1, 2010, and June 1, 2021, were included in this study.
Who cannot join
- patients who have medical treatment
About this study
Official title: Postoperative Morbidity Risk Factors After Surgical Treatment of Perforated Peptic Ulcer: a Retrospective Study of 116 Patients
The main objective of our study is to identify the risk factors for postoperative morbidity after surgical treatment of Perforated peptic ulcer
Read the detailed description
the investigators conducted a retrospective study of 116 patients, operated on for a perforated peptic ulcer, carried out in the General Surgery Department of Taher Sfar University Hospital in Mahdia over a period of 11 years 6 months.
- Conditions
- Peptic Ulcer Perforation
- Being tested
- Primary closure with or without omental grafting
- Keywords
- Postoperative complication, Risk factor
- Medical subject headings
- Peptic Ulcer Perforation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary closure with or without omental graftingProcedure or surgery
Primary closure with or without omental grafting
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative medical or surgical complication
the investigators determined the number of Participants With postoperative medical or surgical complication after surgical treatement of perforated ulcer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Jan 2010
- Primary completion1 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic 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-control
- Time perspective
- Retrospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghannouchi Mossaab, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489497
- Sponsor's protocol ID
- perforated ulcer
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Morbidity Risk Factors After Surgical Treatment of Perforated Peptic Ulcer: a Retrospective Study of 116 Patients
- ClinicalTrials.gov ID
- NCT05489497
- Acronym / sponsor ID
- perforated ulcer
- Conditions
- Peptic Ulcer Perforation
- Keywords
- Postoperative complication, Risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Aug 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.
The main objective of our study is to identify the risk factors for postoperative morbidity after surgical treatment of Perforated peptic ulcer
Detailed description
the investigators conducted a retrospective study of 116 patients, operated on for a perforated peptic ulcer, carried out in the General Surgery Department of Taher Sfar University Hospital in Mahdia over a period of 11 years 6 months.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who presented to tahar sfar hospital for perforated ulcer
Key inclusion criteria (1 listed)
- patients who underwent surgery for a perforated peptic ulcer in the General Surgery Department of Taher Sfar University Hospital in Mahdia, between January 1, 2010, and June 1, 2021, were included in this study.
Key exclusion criteria (1 listed)
- patients who have medical treatment
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 |
|---|---|---|
| Primary closure with or without omental graftingPrimary closure with or without omental grafting | Procedure or surgery | – |
Primary outcome
postoperative medical or surgical complication
Time frame: baseline
the investigators determined the number of Participants With postoperative medical or surgical complication after surgical treatement of perforated ulcer
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 5 Aug 2022.
Related trials for Peptic Ulcer Perforation
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
Not yet recruiting
Falciformopexy for Treatment Perforated Peptic Ulcer.
Perforated Peptic Ulcer
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 Peptic Ulcer Perforation, run by University of Monastir.
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 5 Aug 2022. 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?
postoperative medical or surgical complication (time frame: baseline). 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 5 Aug 2022.