Perforated Peptic UlcerNCT05699616
Management of Perforated Peptic Ulcer
An observational study of Perforated Peptic Ulcer, run by South Valley University at 1 site in Egypt.
Trial summary
Perforated peptic ulcer (PPU) is a common surgical emergency. Exploratory laparotomy and repair with the omental patch are routine surgical intervention till now. In developing counties, laparoscopic repair is still not considered the gold standard in this emergency condition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Perforated Peptic Ulcer
- What is being tested?
- Repair of perforated peptic ulcer
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2023to 30 Apr 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 80 years
- All sexes
- Adult, Older adult
Study population: All patients with perforated peptic ulcer admitted to our hospital in last 4 years and underwent surgical intervention.
Who may be able to join
- All patients with perforated peptic ulcer admitted to our hospital in last 4 years and underwent surgical intervention.
Who cannot join
- Uncompleted patents files.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Management of Perforated Peptic Ulcer: Multicenter Experience
Perforated peptic ulcer (PPU) is a common surgical emergency. Exploratory laparotomy and repair with the omental patch are routine surgical intervention till now. In developing counties, laparoscopic repair is still not considered the gold standard in this emergency condition. This study was conducted to evaluate laparoscopic management of PPU in terms of peri-operative outcomes.
Read the detailed description
Files of all patients admitted to our hospital with perforated peptic ulcer in the last 4 years and underwent operative management.
Demographic, clinical and perioperative outcomes will be collected tabulated and analyzed.
- Conditions
- Perforated Peptic Ulcer
- Being tested
- Repair of perforated peptic ulcer
- Keywords
- Peptic ulcer, Laparoscopic repair, Open repair, Graham Patch
- Medical subject headings
- Peptic Ulcer Perforation, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of perforated peptic ulcerProcedure or surgery
Repair of perforated peptic ulcer either open or laparoscopic.
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time from skin incision to skin closure
Measured: 2 hours
Leakage
Leakage from the repair
Measured: 5 days
Time to return to normal daily activities.
Time to return to normal daily activities after surgery.
Measured: 2 weeks
Perioperative complications
Any encountered perioperative complications related to surgical intervention..
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 Jan 2023
- Primary completion20 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perforated Peptic UlcerStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mohamed Taha Aly, South Valley University
- Investigators
- Abdallah M Taha, MD, Principal investigator, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699616
- Sponsor's protocol ID
- SVU-MED-SUR011-4-22-10-466
- Status last verified
- Oct 2023
- First submitted
- 17 Jan 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertleff MJ, Halm JA, Bemelman WA, van der Ham AC, van der Harst E, Oei HI, Smulders JF, Steyerberg EW, Lange JF. Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial. World J Surg. 2009 Jul;33(7):1368-73. doi: 10.1007/s00268-009-0054-y.
PubMed 19430829Lunevicius R, Morkevicius M. Management strategies, early results, benefits, and risk factors of laparoscopic repair of perforated peptic ulcer. World J Surg. 2005 Oct;29(10):1299-310. doi: 10.1007/s00268-005-7705-4.
PubMed 16132404Katkhouda N, Mavor E, Mason RJ, Campos GM, Soroushyari A, Berne TV. Laparoscopic repair of perforated duodenal ulcers: outcome and efficacy in 30 consecutive patients. Arch Surg. 1999 Aug;134(8):845-8; discussion 849-50. doi: 10.1001/archsurg.134.8.845.
PubMed 10443807Lagoo S, McMahon RL, Kakihara M, Pappas TN, Eubanks S. The sixth decision regarding perforated duodenal ulcer. JSLS. 2002 Oct-Dec;6(4):359-68.
PubMed 12500837Quah GS, Eslick GD, Cox MR. Laparoscopic Repair for Perforated Peptic Ulcer Disease Has Better Outcomes Than Open Repair. J Gastrointest Surg. 2019 Mar;23(3):618-625. doi: 10.1007/s11605-018-4047-8. Epub 2018 Nov 21.
PubMed 30465190
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Management of Perforated Peptic Ulcer: Multicenter Experience
- ClinicalTrials.gov ID
- NCT05699616
- Acronym / sponsor ID
- SVU-MED-SUR011-4-22-10-466
- Conditions
- Perforated Peptic Ulcer
- Keywords
- Peptic ulcer, Laparoscopic repair, Open repair, Graham Patch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 26 Jan 2023 (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 (PPU) is a common surgical emergency. Exploratory laparotomy and repair with the omental patch are routine surgical intervention till now. In developing counties, laparoscopic repair is still not considered the gold standard in this emergency condition. This study was conducted to evaluate laparoscopic management of PPU in terms of peri-operative outcomes.
Detailed description
Files of all patients admitted to our hospital with perforated peptic ulcer in the last 4 years and underwent operative management.
Demographic, clinical and perioperative outcomes will be collected tabulated and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with perforated peptic ulcer admitted to our hospital in last 4 years and underwent surgical intervention.
Key inclusion criteria (1 listed)
- All patients with perforated peptic ulcer admitted to our hospital in last 4 years and underwent surgical intervention.
Key exclusion criteria (1 listed)
- Uncompleted patents files.
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 |
|---|---|---|
| Repair of perforated peptic ulcerRepair of perforated peptic ulcer either open or laparoscopic. | Procedure or surgery | – |
Primary outcome
Operative time
Time frame: 2 hours
Time from skin incision to skin closure
Leakage
Time frame: 5 days
Leakage from the repair
Time to return to normal daily activities.
Time frame: 2 weeks
Time to return to normal daily activities after surgery.
Perioperative complications
Time frame: 1 month
Any encountered perioperative complications related to surgical intervention..
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 24 Oct 2023.
- Background: PubMed 19430829Bertleff MJ, Halm JA, Bemelman WA, van der Ham AC, van der Harst E, Oei HI, Smulders JF, Steyerberg EW, Lange JF. Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial. World J Surg. 2009 Jul;33(7):1368-73. doi: 10.1007/s00268-009-0054-y.
- Background: PubMed 16132404Lunevicius R, Morkevicius M. Management strategies, early results, benefits, and risk factors of laparoscopic repair of perforated peptic ulcer. World J Surg. 2005 Oct;29(10):1299-310. doi: 10.1007/s00268-005-7705-4.
- Background: PubMed 10443807Katkhouda N, Mavor E, Mason RJ, Campos GM, Soroushyari A, Berne TV. Laparoscopic repair of perforated duodenal ulcers: outcome and efficacy in 30 consecutive patients. Arch Surg. 1999 Aug;134(8):845-8; discussion 849-50. doi: 10.1001/archsurg.134.8.845.
- Background: PubMed 12500837Lagoo S, McMahon RL, Kakihara M, Pappas TN, Eubanks S. The sixth decision regarding perforated duodenal ulcer. JSLS. 2002 Oct-Dec;6(4):359-68.
- Background: PubMed 30465190Quah GS, Eslick GD, Cox MR. Laparoscopic Repair for Perforated Peptic Ulcer Disease Has Better Outcomes Than Open Repair. J Gastrointest Surg. 2019 Mar;23(3):618-625. doi: 10.1007/s11605-018-4047-8. Epub 2018 Nov 21.
- Individual participant dataSharing planned: No
Related trials for Perforated Peptic Ulcer
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.
Abdallah M Taha, MD principal investigator
South Valley University
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 Perforated Peptic Ulcer, run by South Valley 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 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 24 Oct 2023. 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?
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?
Operative time (time frame: 2 hours). The study lists 4 primary outcomes in all. 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 NCT05699616, which also lists 5 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 24 Oct 2023.