Text Size

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
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Hospital General de Agudos “Dr. Cosme Argerich”:

Primary Outcome Measures:
  • 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".


Secondary Outcome Measures:
  • 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


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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084070

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

No publications provided

Responsible Party: Klappenbach Roberto, Investigator, Hospital General de Agudos "Dr. Cosme Argerich"
ClinicalTrials.gov Identifier: NCT01084070     History of Changes
Other Study ID Numbers: ARGERICH1
Study First Received: March 9, 2010
Last Updated: June 11, 2012
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by Hospital General de Agudos “Dr. Cosme Argerich”:
early feeding
postoperative care
emergency surgery

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013