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Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klappenbach Roberto, Hospital General de Agudos "Dr. Cosme Argerich"
ClinicalTrials.gov Identifier:
NCT01084070
First received: March 9, 2010
Last updated: June 11, 2012
Last verified: June 2012

March 9, 2010
June 11, 2012
March 2010
July 2011   (final data collection date for primary outcome measure)
Postoperative Complications [ Time Frame: At 30 days or at discharge ] [ Designated as safety issue: Yes ]
The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".
Same as current
Complete list of historical versions of study NCT01084070 on ClinicalTrials.gov Archive Site
  • Gastrointestinal leaks [ Time Frame: At 30 days or at discharge ] [ Designated as safety issue: Yes ]
    "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 ] [ Designated as safety issue: Yes ]
    Time from surgery to the first flatus or deposition, whatever occurs first
  • Oral diet intolerance [ Time Frame: At 30 days or at discharge ] [ Designated as safety issue: Yes ]
    The appearance of vomits or abdominal pain after diet
  • Postoperative hospital stay [ Time Frame: At 90 days ] [ Designated as safety issue: No ]
    Postoperative hospital stay
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Postoperative Care
  • Other: Early oral feeding
    Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.
  • 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.
  • Experimental: Early oral feeding
    Intervention: Other: Early oral feeding
  • Active Comparator: Traditional Care
    Intervention: Other: Traditional Care
Klappenbach RF, Yazyi FJ, Alonso Quintas F, Horna ME, Alvarez Rodríguez J, Oría 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
September 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01084070
ARGERICH1
No
Klappenbach Roberto, Hospital General de Agudos "Dr. Cosme Argerich"
Hospital General de Agudos “Dr. Cosme Argerich”
Not Provided
Principal Investigator: Roberto F Klappenbach, MD Argerich Hospital
Hospital General de Agudos “Dr. Cosme Argerich”
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP