Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Phase 3

Completed

• Conditions: Postoperative Care
• Interventions: Other: Early oral feeding; Other: Traditional Care

• Registration Number: NCT01084070
• Lead Sponsor: Hospital General de Agudos "Dr. Cosme Argerich"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 336

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early oral feeding	Early oral feeding	-
Traditional Care	Traditional Care	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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"
Time to resume bowel functions	At 30 days or at discharge	Time from surgery to the first flatus or deposition, whatever occurs first
Oral diet intolerance	At 30 days or at discharge	The appearance of vomits or abdominal pain after diet
Postoperative hospital stay	At 90 days	Postoperative hospital stay

Trial Locations

Locations (1)

Argerich Hospital; 🇦🇷 Buenos Aires, Argentina