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Enhanced Recovery After Surgery in Major Intrabdominal Procedures.

This study has been completed.
Sponsor:
Information provided by:
St. Andrew's General Hospital, Patras, Greece
ClinicalTrials.gov Identifier:
NCT01400711
First received: June 20, 2011
Last updated: July 21, 2011
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Complication of Surgical and Medical Care.
 Other: ERAS perioperative care
Other: Traditional

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Surgery (ERAS) Versus Conventional Postoperative Care in Patients Undergoing Major Intra-abdominal Surgery.

Further study details as provided by St. Andrew's General Hospital, Patras, Greece:

Primary Outcome Measures:
  • Morbidity. [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality. [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective surgery
  • ASA grade < 4

Exclusion Criteria:

  • Emergency surgery
  • ASA grade > 3
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400711

Locations
Greece
St. Andrew General Hospital, Department of Surgery
Patra, Greece, 26441
Sponsors and Collaborators
St. Andrew's General Hospital, Patras, Greece
  More Information

Publications:

Responsible Party: Vassilios Alivizatos MD, Ph.D, St. Andrew General Hospital, Department of Surgery, Patra, Greece
ClinicalTrials.gov Identifier: NCT01400711     History of Changes
Other Study ID Numbers: 1VA
Study First Received: June 20, 2011
Last Updated: July 21, 2011
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by St. Andrew's General Hospital, Patras, Greece:
Fast-tract surgery, Enhanced recovery after surgery, multimodal surgery.

ClinicalTrials.gov processed this record on May 16, 2013