Perforated Peptic UlcerNCT06484699
Open Versus Laparoscopic Repair of Perforated Peptic Ulcer
A study testing open repair of perforated peptic ulcer and laparoscopic repair of perforated peptic ulcer in people with Perforated Peptic Ulcer, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at Sohag University Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perforated Peptic Ulcer
- What is being tested?
- open repair of perforated peptic ulcer and laparoscopic repair of perforated peptic ulcer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2024to 25 Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with a clinical diagnosis of perforated peptic ulcer that are fit to undergo surgery either via laparotomy or laparoscopy, males or females, any age, with gastric or duodenal ulcer, with American Society of Anesthesiologists (ASA) grade I, II, III.
Who cannot join
- Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
- Patients with associated pathology other than perforated peptic ulcer.
- Patients with American Society of Anesthesiologists (ASA) grade IV, V, VI.
Trial locations and contacts
1 site in 1 country.
Ayman M Ahmad, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, professor
About this study
Official title: Open Versus Laparoscopic Repair of Perforated Peptic Ulcer in Sohag
The aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at Sohag University Hospital. The study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.
- Conditions
- Perforated Peptic Ulcer
- Being tested
- open repair of perforated peptic ulcer, laparoscopic repair of perforated peptic ulcer
- Medical subject headings
- Peptic Ulcer Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open repair of perforated peptic ulcerProcedure or surgery
group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach
laparoscopic repair of perforated peptic ulcerProcedure or surgery
group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach
| Study group | Role | What they receive |
|---|---|---|
| open repair of perforated peptic ulcer | Active comparator | group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach Receives: Procedure: open repair of perforated peptic ulcer |
| laparoscopic repair of perforated peptic ulcer | Active comparator | group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach Receives: Procedure: laparoscopic repair of perforated peptic ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative follow up for repair of perforated peptic ulcer
resumption of oral intake
Measured: 3 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start13 May 2024
- Primary completion25 Jun 2025 (estimated)
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Perforated Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussam Fathy Muhammad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484699
- Sponsor's protocol ID
- Soh-Med-24-05-05MS
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lanas A, Chan FKL. Peptic ulcer disease. Lancet. 2017 Aug 5;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7. Epub 2017 Feb 25.
PubMed 28242110Tarasconi A, Coccolini F, Biffl WL, Tomasoni M, Ansaloni L, Picetti E, Molfino S, Shelat V, Cimbanassi S, Weber DG, Abu-Zidan FM, Campanile FC, Di Saverio S, Baiocchi GL, Casella C, Kelly MD, Kirkpatrick AW, Leppaniemi A, Moore EE, Peitzman A, Fraga GP, Ceresoli M, Maier RV, Wani I, Pattonieri V, Perrone G, Velmahos G, Sugrue M, Sartelli M, Kluger Y, Catena F. Perforated and bleeding peptic ulcer: WSES guidelines. World J Emerg Surg. 2020 Jan 7;15:3. doi: 10.1186/s13017-019-0283-9. eCollection 2020.
PubMed 31921329Lau JY, Sung J, Hill C, Henderson C, Howden CW, Metz DC. Systematic review of the epidemiology of complicated peptic ulcer disease: incidence, recurrence, risk factors and mortality. Digestion. 2011;84(2):102-13. doi: 10.1159/000323958. Epub 2011 Apr 14.
PubMed 21494041
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Laparoscopic Repair of Perforated Peptic Ulcer in Sohag
- ClinicalTrials.gov ID
- NCT06484699
- Acronym / sponsor ID
- Soh-Med-24-05-05MS
- Conditions
- Perforated Peptic Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 25 Jun 2025 (estimated)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 3 Jul 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.
The aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at Sohag University Hospital. The study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open repair of perforated peptic ulcer | Active comparator | Procedure: open repair of perforated peptic ulcergroup (A) includes patients with perforated peptic ulcer that will be operated by open repair approach |
| laparoscopic repair of perforated peptic ulcer | Active comparator | Procedure: laparoscopic repair of perforated peptic ulcergroup (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with a clinical diagnosis of perforated peptic ulcer that are fit to undergo surgery either via laparotomy or laparoscopy, males or females, any age, with gastric or duodenal ulcer, with American Society of Anesthesiologists (ASA) grade I, II, III.
Key exclusion criteria (3 listed)
- Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
- Patients with associated pathology other than perforated peptic ulcer.
- Patients with American Society of Anesthesiologists (ASA) grade IV, V, VI.
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 |
|---|---|---|
| open repair of perforated peptic ulcergroup (A) includes patients with perforated peptic ulcer that will be operated by open repair approach | Procedure or surgery | open repair of perforated peptic ulcer |
| laparoscopic repair of perforated peptic ulcergroup (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach | Procedure or surgery | laparoscopic repair of perforated peptic ulcer |
Primary outcome
Early postoperative follow up for repair of perforated peptic ulcer
Time frame: 3 days after the operation
resumption of oral intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 28242110Lanas A, Chan FKL. Peptic ulcer disease. Lancet. 2017 Aug 5;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7. Epub 2017 Feb 25.
- Background: PubMed 31921329Tarasconi A, Coccolini F, Biffl WL, Tomasoni M, Ansaloni L, Picetti E, Molfino S, Shelat V, Cimbanassi S, Weber DG, Abu-Zidan FM, Campanile FC, Di Saverio S, Baiocchi GL, Casella C, Kelly MD, Kirkpatrick AW, Leppaniemi A, Moore EE, Peitzman A, Fraga GP, Ceresoli M, Maier RV, Wani I, Pattonieri V, Perrone G, Velmahos G, Sugrue M, Sartelli M, Kluger Y, Catena F. Perforated and bleeding peptic ulcer: WSES guidelines. World J Emerg Surg. 2020 Jan 7;15:3. doi: 10.1186/s13017-019-0283-9. eCollection 2020.
- Background: PubMed 21494041Lau JY, Sung J, Hill C, Henderson C, Howden CW, Metz DC. Systematic review of the epidemiology of complicated peptic ulcer disease: incidence, recurrence, risk factors and mortality. Digestion. 2011;84(2):102-13. doi: 10.1159/000323958. Epub 2011 Apr 14.
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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.
Ayman M Ahmad, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open repair of perforated peptic ulcer and laparoscopic repair of perforated peptic ulcer in people with Perforated Peptic Ulcer, run by Sohag University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 15 Jun 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussam F Muhammad, Resident (01090272797, hossamfathyshabeb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative follow up for repair of perforated peptic ulcer (time frame: 3 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06484699, which also lists 3 linked publications.
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 15 Jun 2025.