ClinicalTrials.gg
RecruitingNCT06484699Updated Jun 15, 2025

Open Versus Laparoscopic Repair of Perforated Peptic Ulcer

An interventional study of open repair of perforated peptic ulcer and laparoscopic repair of perforated peptic ulcer in Perforated Peptic Ulcer, sponsored by Sohag University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study 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. The study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.

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Conditions studied

  • Perforated Peptic Ulcer
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In context

Peptic Ulcer Perforation

21 studies on the registry are indexed under Peptic Ulcer Perforation; 4 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 16 interventional studies indexed under Peptic Ulcer Perforation.

Browse Peptic Ulcer Perforation studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (ASA) grade I, II, III.

Exclusion criteria

Exclusion Criteria:

  • Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
  • Patients with associated pathology other than perforated peptic ulcer.
  • Patients with (ASA) grade IV, V, VI.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    open repair of perforated peptic ulcer

    group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach

    Procedure: open repair of perforated peptic ulcer

  • Active comparator
    laparoscopic repair of perforated peptic ulcer

    group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach

    Procedure: laparoscopic repair of perforated peptic ulcer

Interventions

  • Procedureopen repair of perforated peptic ulcer

    group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach

  • Procedurelaparoscopic repair of perforated peptic ulcer

    group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach

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What researchers measure

Primary outcomes

  1. Early postoperative follow up for repair of perforated peptic ulcer

    resumption of oral intake

    Time frame: 3 days after the operation

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Study locations

1 of 1 sites recruiting
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References and documents

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 28242110 ↗
  • Tarasconi 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 31921329 ↗
  • Lau 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2024 (actual). Primary completion is estimated for Jun 2025, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2024
First posted
Jul 3, 2024
StartActual
May 13, 2024
Primary completionEst.
Jun 25, 2025
CompletionEst.
Jun 25, 2025
Last update
Jun 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06484699
Lead sponsor
Sohag University
Responsible party
Hussam Fathy Muhammad (Resident, Department of General Surgery, Faculty of Medicine, Sohag University, Sohag University) — Principal investigator
First posted
Jul 3, 2024
Start date
May 13, 2024
Primary completion
Jun 25, 2025 (estimated)
Completion
Jun 25, 2025 (estimated)
Last update
Jun 15, 2025

Study contacts

Hussam F Muhammad, Resident
Contact
hossamfathyshabeb@gmail.com
01090272797
Ayman M Ahmad, Professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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