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

Cairo University100 enrolled

Overview

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 :(

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Peptic Ulcer Perforation

Interventions

Post operative early oral feedingOTHER

To start oral feeding 6 hours after perforated peptic ulcer repairs

Traditional delayed oral Feeding Post-perforated Peptic Ulcer RepairsOTHER

To start oral feeding after 48 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

number of days of hospital stay

Time frame: Up to 10 days

days needed for frist Bowel motion

number of days before frist bowel motion

Time frame: 7 days

Secondary Outcomes

incidence of Post operative repair leak

number of Post operative repair leaks

Time frame: 30 days

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

INCIDENCE OF postoperative nausea and vomiting (PONAV)

number of cases with postoperative nausea and vomiting (PONAV)

Time frame: 7 days

incidence of Surgical site infection

number of cases complicated with surgical site infection

Time frame: 30 days

incidence of Pulmonary complications

number of cases complicated Pulmonary complications

Time frame: 30 days

incidence of Ryle reinsertion

number of cases complicated Ryle reinsertion

Time frame: 7 days

number of Readmission cases

number of cases complicated Readmission cases

Data from ClinicalTrials.gov

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