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Completed

NCT Number: NCT01084070

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.

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Key information

Conditions

Postoperative Care

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Argerich Hospital

Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early oral feeding

Other

Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.

traditional care

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital General de Agudos "Dr. Cosme Argerich"

Other

Registry information

Official study title

Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2010
Registry last updated
Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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