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Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084070
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : June 12, 2012
Information provided by (Responsible Party):
Klappenbach Roberto, Hospital General de Agudos “Dr. Cosme Argerich”

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.

Condition or disease Intervention/treatment Phase
Postoperative Care Other: Early oral feeding Other: Traditional Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
Study Start Date : March 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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"

  2. 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

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

  4. Postoperative hospital stay [ Time Frame: At 90 days ]
    Postoperative hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01084070

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Argerich Hospital
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital General de Agudos “Dr. Cosme Argerich”
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Principal Investigator: Roberto F Klappenbach, MD Argerich Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Klappenbach Roberto, Investigator, Hospital General de Agudos “Dr. Cosme Argerich” Identifier: NCT01084070    
Other Study ID Numbers: ARGERICH1
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012
Keywords provided by Klappenbach Roberto, Hospital General de Agudos “Dr. Cosme Argerich”:
early feeding
postoperative care
emergency surgery
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes