Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
1 other identifier
interventional
336
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 9, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 12, 2012
June 1, 2012
1.3 years
March 9, 2010
June 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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 Arms (2)
Early oral feeding
EXPERIMENTALTraditional Care
ACTIVE COMPARATORInterventions
Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.
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.
Eligibility Criteria
You may qualify if:
- Patients over 14 years after abdominal emergency surgery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Argerich Hospital
Buenos Aires, Buenos Aires, Argentina
Related Publications (1)
Klappenbach RF, Yazyi FJ, Alonso Quintas F, Horna ME, Alvarez Rodriguez J, Oria A. Early oral feeding versus traditional postoperative care after abdominal emergency surgery: a randomized controlled trial. World J Surg. 2013 Oct;37(10):2293-9. doi: 10.1007/s00268-013-2143-1.
PMID: 23807124DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto F Klappenbach, MD
Argerich Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
March 9, 2010
First Posted
March 10, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2011
Study Completion
September 1, 2011
Last Updated
June 12, 2012
Record last verified: 2012-06