Enhanced Recovery After Surgery in Major Intrabdominal Procedures.

NCT ID: NCT01400711

Last Updated: 2011-07-22

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

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-04-30

Brief Summary

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Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating the stress response to surgery and enabling rapid recovery. There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of traditional treatment. However, few studies exist about the implication of ERAS programs in major upper abdominal surgery patients.

The aim of this study was to compare morbidity, mortality and length of stay in patients undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving either conventional postoperative care or an ERAS program.

Detailed Description

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Conditions

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Complication of Surgical and Medical Care.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ERAS patients

Patients planned to undergoing major intrabdominal surgery, following the ERAS perioperative care.

Group Type ACTIVE_COMPARATOR

ERAS perioperative care

Intervention Type OTHER

Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.

Control patients

Patients planned to undergo major intrabdominal surgery, following the conventional perioperative care.

Group Type ACTIVE_COMPARATOR

Traditional

Intervention Type OTHER

Nasogastric tube until bowel function, late oral eating, opioid analgesics.

Interventions

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ERAS perioperative care

Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.

Intervention Type OTHER

Traditional

Nasogastric tube until bowel function, late oral eating, opioid analgesics.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Elective surgery
* ASA grade \< 4

Exclusion Criteria

* Emergency surgery
* ASA grade \> 3
Minimum Eligible Age

20 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Andrew's General Hospital, Patras, Greece

OTHER

Sponsor Role lead

Responsible Party

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St. Andrew General Hospital, Department of Surgery, Patra, Greece

Locations

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St. Andrew General Hospital, Department of Surgery

Pátrai, , Greece

Site Status

Countries

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Greece

References

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Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.

Reference Type RESULT
PMID: 19841366 (View on PubMed)

Other Identifiers

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1VA

Identifier Type: -

Identifier Source: org_study_id

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