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CompletedNCT06042933Updated Aug 29, 2025

Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair

An interventional study of Post operative early oral feeding and Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs in Peptic Ulcer Perforation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.

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

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2023, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population \& Sample size :(

Read the detailed description

Study Design:

This study is a single-center, prospective, parallel arm, randomized controlled trial. Patients will be randomly assigned in 1:1 ratio to receive either delayed oral feeding or early oral feeding.

Methods:

Patients will be randomly assigned into two groups. Group A patients followed an early oral feeding protocol(12 hours), and Group B received delayed oral feeding (72 hours).

Outcome parameter :

The outcomes are incidence of postoperative complications including Postoperative repair leakage, Infection-related postoperative complications , Number of days of hospital stay and return of bowel function and Diet intolerance.

02

Conditions studied

  • Peptic Ulcer Perforation
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

- All consecutive patients, of age 18 years and above, who were

presented to the emergency surgical team and were diagnosed with perforated duodenal ulcer by surgicalteam, were recruited and assessed for eligibility.

Exclusion criteria

Exclusion Criteria:

    • Preoperative septic shock on admission.

      • Delayed presentation more than 24 hours.
      • 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 .
      • grade iii/iv, or had an alternative perioperative diagnosis.
      • Intraoperatively, after randomization, patients were excluded based on the following criteria: perforated duodenal ulcer ≥20 mm, consistent with malignant ulcers.
Terms in these criteria, in plain language(5)

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.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Group A

    early oral intake 6 hours postoperative.

    Other: Post operative early oral feeding

  • Active comparator
    Group B

    delayed oral intake after 72 hours

    Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs

Interventions

  • OtherPost operative early oral feeding

    To start oral feeding 6 hours after perforated peptic ulcer repairs

  • OtherTraditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs

    To start oral feeding after 48 hours

06

What researchers measure

Primary outcomes

  1. number of days of hospital stay

    number of days of hospital stay

    Time frame: Up to 10 days

  2. days needed for frist Bowel motion

    number of days before frist bowel motion

    Time frame: 7 days

Secondary outcomes

  1. incidence of Post operative repair leak

    number of Post operative repair leaks

    Time frame: 30 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)

    number of cases with postoperative nausea and vomiting (PONAV)

    Time frame: 7 days

  4. incidence of Surgical site infection

    number of cases complicated with surgical site infection

    Time frame: 30 days

  5. incidence of Pulmonary complications

    number of cases complicated Pulmonary complications

    Time frame: 30 days

  6. incidence of Ryle reinsertion

    number of cases complicated Ryle reinsertion

    Time frame: 7 days

  7. number of Readmission cases

    number of cases complicated Readmission cases

    Time frame: 30 days

07

Study locations

1 site
  • Cairo University
    Cairo, 11511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06042933
Lead sponsor
Cairo University
Responsible party
Mohammed Elshwadfy Nageeb (lecturer of general surgery, Cairo University) — Principal investigator
First posted
Sep 21, 2023
Start date
Mar 2, 2023
Primary completion
Oct 25, 2024
Completion
Nov 1, 2024
Last update
Aug 29, 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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