Peptic Ulcer Perforation
Conditions
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.
Interventions
OTHERPost operative early oral feeding
To start oral feeding 6 hours after perforated peptic ulcer repairs
OTHERTraditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs
To start oral feeding after 48 hours
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| INCIDENCE OF postoperative nausea and vomiting (PONAV) | 7 days | number of cases with postoperative nausea and vomiting (PONAV) |
| incidence of Surgical site infection | 30 days | number of cases complicated with surgical site infection |
| incidence of Post operative repair leak | 30 days | number of Post operative repair leaks |
| incidence of Ryle reinsertion | 7 days | number of cases complicated Ryle reinsertion |
| number of Readmission cases | 30 days | number of cases complicated Readmission cases |
| incidence of Pulmonary complications | 30 days | number of cases complicated Pulmonary complications |
| severity of operative pain measured by Visual Analogue Scale (VAS) | 7 days | from 1 to 10 1 indicated minimum pain and 10 maximum pain |
Countries
Egypt
Outcome results
None listed