Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Postoperative Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084070
• Other study ID #: ARGERICH1
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2010
• Last updated: June 11, 2012
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Hospital General de Agudos “Dr. Cosme Argerich”
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Emergencies
• Postoperative Care

Intervention

Other:
• Early oral feeding
Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.
• 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.

Locations

Country	Name	City	State
Argentina	Argerich Hospital	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Agudos “Dr. Cosme Argerich”

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Complications	The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".	At 30 days or at discharge	Yes
Secondary	Gastrointestinal leaks	"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"	At 30 days or at discharge	Yes
Secondary	Time to resume bowel functions	Time from surgery to the first flatus or deposition, whatever occurs first	At 30 days or at discharge	Yes
Secondary	Oral diet intolerance	The appearance of vomits or abdominal pain after diet	At 30 days or at discharge	Yes
Secondary	Postoperative hospital stay	Postoperative hospital stay	At 90 days	No