Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Sponsor
Hospital General de Agudos "Dr. Cosme Argerich" (Other)
Overall Status
Completed
CT.gov ID
NCT01084070
Collaborator
(none)
336
1
2
18
18.6

Study Details

Study Description

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
  • Other: Early oral feeding
  • Other: Traditional Care
Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Postoperative Complications [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 [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 [At 30 days or at discharge]

    Time from surgery to the first flatus or deposition, whatever occurs first

  3. Oral diet intolerance [At 30 days or at discharge]

    The appearance of vomits or abdominal pain after diet

  4. Postoperative hospital stay [At 90 days]

    Postoperative hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Argerich Hospital Buenos Aires Argentina

Sponsors and Collaborators

  • Hospital General de Agudos "Dr. Cosme Argerich"

Investigators

  • Principal Investigator: Roberto F Klappenbach, MD, Argerich Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Klappenbach Roberto, Investigator, Hospital General de Agudos "Dr. Cosme Argerich"
ClinicalTrials.gov Identifier:
NCT01084070
Other Study ID Numbers:
  • ARGERICH1
First Posted:
Mar 10, 2010
Last Update Posted:
Jun 12, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Klappenbach Roberto, Investigator, Hospital General de Agudos "Dr. Cosme Argerich"
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2012