Clinical trial NCT06042933: Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair
Official title: Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peptic Ulcer Perforation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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 :(

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of days of hospital stay
timeFrame: Up to 10 days
measure: days needed for frist Bowel motion
timeFrame: 7 days
Secondary outcomes:
measure: incidence of Post operative repair leak
timeFrame: 30 days
measure: severity of operative pain measured by Visual Analogue Scale (VAS)
timeFrame: 7 days
measure: INCIDENCE OF postoperative nausea and vomiting (PONAV)
timeFrame: 7 days
measure: incidence of Surgical site infection
timeFrame: 30 days
measure: incidence of Pulmonary complications
timeFrame: 30 days
measure: incidence of Ryle reinsertion
timeFrame: 7 days
measure: number of Readmission cases
timeFrame: 30 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: mohammed elshwadfy
role: PRINCIPAL_INVESTIGATOR
References: