Peptic UlcersNCT07050199
Risk Factors Affecting Mortality in Perforated Peptic Ulcer
An observational study of Peptic Ulcers, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial summary
Perforation is one of the most severe and life-threatening complications of peptic ulcer disease. This study aims to evaluate the risk factors associated with postoperative morbidity and mortality in patients undergoing surgery for peptic ulcer perforation, with a focus on the timing of presentation, demographic… Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Peptic Ulcers
- What is being tested?
- Emergency laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2022to 30 Mar 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing emergency laparotomy for peptic ulcer perforation with Graham's patch repair
Who may be able to join
- Patients with peptic ulcer perforation aged> 15 years and <75 years.
- Patients with duodenal or gastric perforation of peptic ulcer origin.
- Patients who underwent simple closure with omental patch as a standard operative procedure.
Who cannot join
- Patients treated with conservative management.
- Patients with perforation of peptic ulcer origin at the jejunum, ileum adjacent to Meckel's diverticulum.
- Patients presenting with recurrent perforation or stomal ulcer perforation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors Affecting Morbidity and Mortality in Perforated Peptic Ulcer
Perforation is one of the most severe and life-threatening complications of peptic ulcer disease. This study aims to evaluate the risk factors associated with postoperative morbidity and mortality in patients undergoing surgery for peptic ulcer perforation, with a focus on the timing of presentation, demographic variables, surgical delay, and their association with postoperative outcomes.
- Conditions
- Peptic Ulcers
- Being tested
- Emergency laparotomy
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency laparotomyProcedure or surgery
Emergency laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Patients with peptic ulcer perforation of age > 15 years and <75 years | Not described Receives: Procedure: Emergency laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Morbidity Rate
Incidence of postoperative complications (e.g., wound infection, sepsis, anastomotic leak, pneumonia) in patients undergoing surgery for perforated peptic ulcer.
Measured: 12 months (from patient enrollment to completion of follow-up)
Postoperative Mortality Rate
Incidence of death following surgical intervention for perforated peptic ulcer.
Measured: 12 months (from patient enrollment to completion of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Apr 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcersStudies 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
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prajjwol Luitel, Maharajgunj Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050199
- Sponsor's protocol ID
- PG-NMC/528/078-079
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Affecting Morbidity and Mortality in Perforated Peptic Ulcer
- ClinicalTrials.gov ID
- NCT07050199
- Acronym / sponsor ID
- PG-NMC/528/078-079
- Conditions
- Peptic Ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 3 Jul 2025 (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.
Perforation is one of the most severe and life-threatening complications of peptic ulcer disease. This study aims to evaluate the risk factors associated with postoperative morbidity and mortality in patients undergoing surgery for peptic ulcer perforation, with a focus on the timing of presentation, demographic variables, surgical delay, and their association with postoperative outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peptic ulcer perforation of age > 15 years and <75 years | – | Procedure: Emergency laparotomy |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing emergency laparotomy for peptic ulcer perforation with Graham's patch repair
Key inclusion criteria (3 listed)
- Patients with peptic ulcer perforation aged> 15 years and <75 years.
- Patients with duodenal or gastric perforation of peptic ulcer origin.
- Patients who underwent simple closure with omental patch as a standard operative procedure.
Key exclusion criteria (3 listed)
- Patients treated with conservative management.
- Patients with perforation of peptic ulcer origin at the jejunum, ileum adjacent to Meckel's diverticulum.
- Patients presenting with recurrent perforation or stomal ulcer perforation.
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 |
|---|---|---|
| Emergency laparotomyEmergency laparotomy | Procedure or surgery | Patients with peptic ulcer perforation of age > 15 years and <75 years |
Primary outcome
Postoperative Morbidity Rate
Time frame: 12 months (from patient enrollment to completion of follow-up)
Incidence of postoperative complications (e.g., wound infection, sepsis, anastomotic leak, pneumonia) in patients undergoing surgery for perforated peptic ulcer.
Postoperative Mortality Rate
Time frame: 12 months (from patient enrollment to completion of follow-up)
Incidence of death following surgical intervention for perforated peptic 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 3 Jul 2025.
- Individual participant dataSharing planned: No
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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 Peptic Ulcers, run by Maharajgunj Medical Campus at 1 site in Nepal.
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 3 inclusion and 3 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 3 Jul 2025. 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 Nepal. 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?
Postoperative Morbidity Rate (time frame: 12 months (from patient enrollment to completion of follow-up)). The study lists 2 primary outcomes in all. 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 3 Jul 2025.