Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

NCT ID: NCT01084070

Last Updated: 2012-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Postoperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Early oral feeding

Group Type EXPERIMENTAL

Early oral feeding

Intervention Type OTHER

Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.

Traditional Care

Group Type ACTIVE_COMPARATOR

Traditional Care

Intervention Type OTHER

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.

Interventions

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Early oral feeding

Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet "at will" indicated.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General de Agudos "Dr. Cosme Argerich"

OTHER

Sponsor Role lead

Responsible Party

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Klappenbach Roberto

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto F Klappenbach, MD

Role: PRINCIPAL_INVESTIGATOR

Argerich Hospital

Locations

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Argerich Hospital

Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type DERIVED
PMID: 23807124 (View on PubMed)

Other Identifiers

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ARGERICH1

Identifier Type: -

Identifier Source: org_study_id

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