ClinicalTrials.gg
CompletedNCT06084741Updated Aug 26, 2025

Omitting Drains After Repair of Peptic Ulcer Perforations

An interventional study of Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations and Using intraabdominal drains in Peptic Ulcer Perforations, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.

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

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2023, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

. This study aimed to evaluate ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries.

Read the detailed description

Patients will be randomly assigned into two groups. In Group A : the investigators will put intraabdominal drains, and in Group ,thd investigators will not put any intraabdominal drains. Our primary outcomes will be hospital stayl engthand pain score;Data analysis packages will be SPSS version 21 Qualitative data will be presented by number and percentage, quantitative data by mean, standard deviation, median and interquartile range.

02

Conditions studied

  • Peptic Ulcer Perforations
03

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 enrollment of 100 is above the median of 66 across 16 interventional studies indexed under Peptic Ulcer Perforation.

Browse Peptic Ulcer Perforation studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
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

- Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study.

Exclusion criteria

Exclusion Criteria:

  • preoperative shock on admission.

    • Delayed presentation more than 24 hours.
    • known malignant gastric ulcers confirmed by histopathology.
    • the presence of neuropsychiatric disease, pregnant and lactating women.
    • predisposing factors for impaired wound healing (e.g., currently using agents, or chronic use of ), the presence of /AIDS.
    • Intraoperative findings consistent with malignant ulcers. • grade III/IV, or had an alternative perioperative diagnosis. • Ulcer size more than 2 cm in diameter.
Terms in these criteria, in plain language(4)

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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.

05

Study design

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

Study arms

  • Active comparator
    Drain group

    In Group A the investigators will put intraabdominal drains

    Other: Using intraabdominal drains

  • Experimental
    No drain group

    The investigators will not put any intraabdominal drains

    Other: Omitting of usage of intraabdominal drains after repair of peptic ulcer perforations

Interventions

  • OtherOmitting of usage of intraabdominal drains after repair of peptic ulcer perforations

    omitting the intraabdominal drains

  • OtherUsing intraabdominal drains

    The investigators will put intraabdominal drains

06

What researchers measure

Primary outcomes

  1. number of days of hospital stay

    hospital stay length

    Time frame: Up to 30 days

  2. number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia

    number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia

    Time frame: 30 days

  3. incidence of Post operative repair leak

    incidence of Post operative repair leak

    Time frame: 30 days

Secondary outcomes

  1. number of days before frist bowel motion

    number of days before frist bowel motion

    Time frame: 7 days

  2. severity of operative pain measured by Visual Analogue Scale (VAS

    from 1 to 10 1 indicated minimum pain and 10 maximum pain

    Time frame: 7 days

  3. INCIDENCE OF postoperative nausea and vomiting (PONAV

    INCIDENCE OF postoperative nausea and vomiting (PONAV

    Time frame: 7 days

07

Study locations

1 site
  • Cairo University
    Cairo, 11511, Egypt
08

References and documents

Publications

  • Nageeb ME, Tobar W, Saqr A, Ragab AA, Elansary AMSEO. No drains versus drains after perforated peptic ulcer repair: A randomized controlled trail. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2137-2145. doi: 10.1007/s00068-024-02551-6. Epub 2024 Jun 15. PubMed 38878063 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2023 to primary completion in Feb 2024, 11 months.

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

Registered
Oct 9, 2023
First posted
Oct 16, 2023
StartActual
Mar 25, 2023
Primary completionActual
Feb 25, 2024
CompletionActual
Mar 25, 2024
Last update
Aug 26, 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 Aug 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06084741
Lead sponsor
Cairo University
Responsible party
Mohammed Elshwadfy Nageeb (Lecturer of general surgery, Cairo University) — Principal investigator
First posted
Oct 16, 2023
Start date
Mar 25, 2023
Primary completion
Feb 25, 2024
Completion
Mar 25, 2024
Last update
Aug 26, 2025

Study contacts

Mohammed ElShwadfy
principal investigator · Cairo University

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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