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Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

Primary Purpose

Postoperative Care

Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Early oral feeding
Traditional Care
Sponsored by
Hospital General de Agudos "Dr. Cosme Argerich"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Care focused on measuring early feeding, postoperative care, emergency surgery

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Argerich Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early oral feeding

Traditional Care

Arm Description

Outcomes

Primary Outcome Measures

Postoperative Complications
The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".

Secondary Outcome Measures

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"
Time to resume bowel functions
Time from surgery to the first flatus or deposition, whatever occurs first
Oral diet intolerance
The appearance of vomits or abdominal pain after diet
Postoperative hospital stay
Postoperative hospital stay

Full Information

First Posted
March 9, 2010
Last Updated
June 11, 2012
Sponsor
Hospital General de Agudos "Dr. Cosme Argerich"
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1. Study Identification

Unique Protocol Identification Number
NCT01084070
Brief Title
Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
Official Title
Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Agudos "Dr. Cosme Argerich"

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Care
Keywords
early feeding, postoperative care, emergency surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early oral feeding
Arm Type
Experimental
Arm Title
Traditional Care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Early oral feeding
Intervention Description
Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.
Intervention Type
Other
Intervention Name(s)
Traditional Care
Intervention Description
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 Outcome Measure Information:
Title
Postoperative Complications
Description
The rate of postoperative complications according with Clavien-Dindo classification, defined as "any deviation from the normal postoperative course".
Time Frame
At 30 days or at discharge
Secondary Outcome Measure Information:
Title
Gastrointestinal leaks
Description
"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 Frame
At 30 days or at discharge
Title
Time to resume bowel functions
Description
Time from surgery to the first flatus or deposition, whatever occurs first
Time Frame
At 30 days or at discharge
Title
Oral diet intolerance
Description
The appearance of vomits or abdominal pain after diet
Time Frame
At 30 days or at discharge
Title
Postoperative hospital stay
Description
Postoperative hospital stay
Time Frame
At 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto F Klappenbach, MD
Organizational Affiliation
Argerich Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Argerich Hospital
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
23807124
Citation
Klappenbach RF, Yazyi FJ, Alonso Quintas F, Horna ME, Alvarez Rodriguez J, Oria A. Early oral feeding versus traditional postoperative care after abdominal emergency surgery: a randomized controlled trial. World J Surg. 2013 Oct;37(10):2293-9. doi: 10.1007/s00268-013-2143-1.
Results Reference
derived

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Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

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