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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | early oral intake 6 hours postoperative. |
|
| Group B | Active Comparator | delayed oral intake after 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post operative early oral feeding | Other | To start oral feeding 6 hours after perforated peptic ulcer repairs |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of days of hospital stay | number of days of hospital stay | Up to 10 days |
| days needed for frist Bowel motion | number of days before frist bowel motion | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of Post operative repair leak | number of Post operative repair leaks | 30 days |
| severity of operative pain measured by Visual Analogue Scale (VAS) | from 1 to 10 1 indicated minimum pain and 10 maximum pain |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| mohammed elshwadfy | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | 11511 | Egypt |
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| ID | Term |
|---|---|
| D010439 | Peptic Ulcer Perforation |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Randomized controlled trial
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| Traditional delayed oral Feeding Post-perforated Peptic Ulcer Repairs | Other | To start oral feeding after 48 hours |
|
| 7 days |
| INCIDENCE OF postoperative nausea and vomiting (PONAV) | number of cases with postoperative nausea and vomiting (PONAV) | 7 days |
| incidence of Surgical site infection | number of cases complicated with surgical site infection | 30 days |
| incidence of Pulmonary complications | number of cases complicated Pulmonary complications | 30 days |
| incidence of Ryle reinsertion | number of cases complicated Ryle reinsertion | 7 days |
| number of Readmission cases | number of cases complicated Readmission cases | 30 days |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |