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NCT Number: NCT06042933

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

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 :(

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • • Preoperative refractory 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 immunosuppressive agents, or chronic use of steroids), the presence of HIV.
  • American society of anesthesiologists 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.

Treatment and study plan

Post operative early oral feeding

Other

To start oral feeding 6 hours after perforated peptic ulcer repairs

Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs

Other

To start oral feeding after 48 hours

Primary outcomes

  1. number of days of hospital stay

    Time frame: Up to 10 days

    number of days of hospital stay

  2. days needed for frist Bowel motion

    Time frame: 7 days

    number of days before frist bowel motion

Secondary outcomes

  1. incidence of Post operative repair leak

    Time frame: 30 days

    number of Post operative repair leaks

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

    Time frame: 7 days

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

  3. INCIDENCE OF postoperative nausea and vomiting (PONAV)

    Time frame: 7 days

    number of cases with postoperative nausea and vomiting (PONAV)

  4. incidence of Surgical site infection

    Time frame: 30 days

    number of cases complicated with surgical site infection

  5. incidence of Pulmonary complications

    Time frame: 30 days

    number of cases complicated Pulmonary complications

  6. incidence of Ryle reinsertion

    Time frame: 7 days

    number of cases complicated Ryle reinsertion

  7. number of Readmission cases

    Time frame: 30 days

    number of cases complicated Readmission cases

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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