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Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

This study has been completed.
Information provided by (Responsible Party):
Klappenbach Roberto, Hospital General de Agudos "Dr. Cosme Argerich" Identifier:
First received: March 9, 2010
Last updated: June 11, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Postoperative Care
Other: Early oral feeding
Other: Traditional Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Resource links provided by NLM:

Further study details as provided by Klappenbach Roberto, Hospital General de Agudos "Dr. Cosme Argerich":

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Gastrointestinal leaks [ Time Frame: At 30 days or at discharge ]
    "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"

  • Time to resume bowel functions [ Time Frame: At 30 days or at discharge ]
    Time from surgery to the first flatus or deposition, whatever occurs first

  • Oral diet intolerance [ Time Frame: At 30 days or at discharge ]
    The appearance of vomits or abdominal pain after diet

  • Postoperative hospital stay [ Time Frame: At 90 days ]
    Postoperative hospital stay

Enrollment: 336
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early oral feeding Other: Early oral feeding
Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.
Active Comparator: Traditional Care Other: Traditional Care
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.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01084070

Argerich Hospital
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital General de Agudos “Dr. Cosme Argerich”
Principal Investigator: Roberto F Klappenbach, MD Argerich Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Klappenbach Roberto, Investigator, Hospital General de Agudos "Dr. Cosme Argerich" Identifier: NCT01084070     History of Changes
Other Study ID Numbers: ARGERICH1
Study First Received: March 9, 2010
Last Updated: June 11, 2012

Keywords provided by Klappenbach Roberto, Hospital General de Agudos "Dr. Cosme Argerich":
early feeding
postoperative care
emergency surgery

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes processed this record on May 25, 2017