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Clinical Trials/NCT01084070
NCT01084070
Completed
Phase 3

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

Hospital General de Agudos "Dr. Cosme Argerich"1 site in 1 country336 target enrollmentMarch 2010
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ConditionsPostoperative Care

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Postoperative Care
Sponsor
Hospital General de Agudos "Dr. Cosme Argerich"
Enrollment
336
Locations
1
Primary Endpoint
Postoperative Complications
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
September 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital General de Agudos "Dr. Cosme Argerich"
Responsible Party
Principal Investigator
Principal Investigator

Klappenbach Roberto

Investigator

Hospital General de Agudos "Dr. Cosme Argerich"

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative Complications

Time Frame: At 30 days or at discharge

The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".

Secondary Outcomes

  • Gastrointestinal leaks(At 30 days or at discharge)
  • Time to resume bowel functions(At 30 days or at discharge)
  • Oral diet intolerance(At 30 days or at discharge)
  • Postoperative hospital stay(At 90 days)

Study Sites (1)

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