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Enhanced Recovery After Surgery in Major Intrabdominal Procedures.

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ClinicalTrials.gov Identifier: NCT01400711
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : July 22, 2011
Information provided by:
St. Andrew's General Hospital, Patras, Greece

Brief Summary:

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 or disease Intervention/treatment
Complication of Surgical and Medical Care. Other: ERAS perioperative care Other: Traditional

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Surgery (ERAS) Versus Conventional Postoperative Care in Patients Undergoing Major Intra-abdominal Surgery.
Study Start Date : October 2010
Primary Completion Date : March 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Morbidity. [ Time Frame: 30 days after surgery ]

Secondary Outcome Measures :
  1. Mortality. [ Time Frame: 30 days after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective surgery
  • ASA grade < 4

Exclusion Criteria:

  • Emergency surgery
  • ASA grade > 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400711

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

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
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: August 2010

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