Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

June 11, 2012 updated by: Klappenbach Roberto, Hospital General de Agudos "Dr. Cosme Argerich"

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Argerich Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
At 30 days or at discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
At 30 days or at discharge
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
At 30 days or at discharge
Oral diet intolerance
Time Frame: At 30 days or at discharge
The appearance of vomits or abdominal pain after diet
At 30 days or at discharge
Postoperative hospital stay
Time Frame: At 90 days
Postoperative hospital stay
At 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Agudos "Dr. Cosme Argerich"

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGERICH1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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