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

Cairo University (CU)

Status: Completed

Conditions: Peptic Ulcer Perforation

Treatments: Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs; Other: Post operative early oral feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06042933

N-96-2023

Details and patient eligibility

About

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 :(

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group A

Experimental group

Description:

early oral intake 6 hours postoperative.

Treatment:

Other: Post operative early oral feeding

Group B

Active Comparator group

Description:

delayed oral intake after 72 hours

Treatment:

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