Enhanced Recovery After Surgery in Major Intrabdominal Procedures.

July 21, 2011 updated by: St. Andrew's General Hospital, Patras, Greece

Enhanced Recovery After Surgery (ERAS) Versus Conventional Postoperative Care in Patients Undergoing Major Intra-abdominal Surgery.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

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

  • Greece
      • Patra, Greece, 26441
        • St. Andrew General Hospital, Department of Surgery

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

20 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgery
  • ASA grade < 4

Exclusion Criteria:

  • Emergency surgery
  • ASA grade > 3

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ERAS patients
Patients planned to undergoing major intrabdominal surgery, following the ERAS perioperative care.
Other: ERAS perioperative care
Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.
Active Comparator: Control patients
Patients planned to undergo major intrabdominal surgery, following the conventional perioperative care.
Other: Traditional
Nasogastric tube until bowel function, late oral eating, opioid analgesics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity.
Time Frame: 30 days after surgery
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality.
Time Frame: 30 days after surgery
30 days after surgery

Collaborators and Investigators

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

Sponsor

St. Andrew's General Hospital, Patras, Greece

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

October 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1VA

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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