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

Not Applicable

Recruiting

• Conditions: Peptic Ulcer Perforation
• Interventions: Other: Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs; Other: Post operative early oral feeding

• Registration Number: NCT06042933
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2023-03-02
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-16
• Primary Completion: 2023-10-25
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs	delayed oral intake after 72 hours
Group A	Post operative early oral feeding	early oral intake 6 hours postoperative.

Primary Outcome Measures

Name	Time	Method
number of days of hospital stay	Up to 10 days	number of days of hospital stay
days needed for frist Bowel motion	7 days	number of days before frist bowel motion

Secondary Outcome Measures

Name	Time	Method
incidence of Post operative repair leak	30 days	number of Post operative repair leaks
number of Readmission cases	30 days	number of cases complicated Readmission cases
severity of operative pain measured by Visual Analogue Scale (VAS)	7 days	from 1 to 10 1 indicated minimum pain and 10 maximum pain
incidence of Surgical site infection	30 days	number of cases complicated with surgical site infection
incidence of Pulmonary complications	30 days	number of cases complicated Pulmonary complications
incidence of Ryle reinsertion	7 days	number of cases complicated Ryle reinsertion
INCIDENCE OF postoperative nausea and vomiting (PONAV)	7 days	number of cases with postoperative nausea and vomiting (PONAV)

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt