Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
|ClinicalTrials.gov Identifier: NCT01084070|
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : June 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Care||Other: Early oral feeding Other: Traditional Care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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".
- 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"
- 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
- Oral diet intolerance [ Time Frame: At 30 days or at discharge ]The appearance of vomits or abdominal pain after diet
- Postoperative hospital stay [ Time Frame: At 90 days ]Postoperative hospital stay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084070
|Buenos Aires, Argentina|
|Principal Investigator:||Roberto F Klappenbach, MD||Argerich Hospital|