Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Study Overview
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Brief Summary
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The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.

Official Title
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Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Conditions
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Postoperative Care

Intervention / Treatment
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* Other: Early oral feeding
* Other: Traditional Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 14 years after abdominal emergency surgery. Exclusion Criteria: Lack of consensus of the patient Concurrent extra-abdominal surgery Short bowel or other clear indication of parenteral nutrition Inability to feed orally (eg, decreased level of consciousness) Interventional procedure Esophageal surgery Reoperations Pancreatitis

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early oral feeding<br> | Other: Early oral feeding<br>* Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet at will indicated.<br>|
| Active Comparator: Traditional Care<br> | Other: Traditional Care<br>* They will have nasogastric tube and restriction of oral intake until the first sign of restoration of intestinal transit (first flatus or stool, whichever comes first). Since then withdrew nasogastric tube and liquid diet starts within 24 hours, then continues with soft diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | The rate of postoperative complications according with Clavien-Dindo classification, defined as any deviation from the normal postoperative course. | At 30 days or at discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal leaks | the leak of luminal contents from a surgical join between two hollow viscera or from surgical repair of continuity solution. The luminal contents may emerge either through the wound or at the drain site, or they may collect near the anastomosis or rapair, causing fever, abscess, septicaemia, metabolic disturbance and/or multiple-organ failure. The escape of luminal contents intoan adjacent localised area, detected by imaging, in the absence of clinical symptoms and signs should be recorded as a subclinical leak | At 30 days or at discharge | 
| Time to resume bowel functions | Time from surgery to the first flatus or deposition, whatever occurs first | At 30 days or at discharge | 
| Oral diet intolerance | The appearance of vomits or abdominal pain after diet | At 30 days or at discharge | 
| Postoperative hospital stay | Postoperative hospital stay | At 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early feeding, postoperative care, emergency surgery