Enhanced Recovery After Surgery in Major Intrabdominal Procedures.
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 20, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedJuly 22, 2011
August 1, 2010
5 months
June 20, 2011
July 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morbidity.
30 days after surgery
Secondary Outcomes (1)
Mortality.
30 days after surgery
Study Arms (2)
ERAS patients
ACTIVE COMPARATORPatients planned to undergoing major intrabdominal surgery, following the ERAS perioperative care.
Control patients
ACTIVE COMPARATORPatients planned to undergo major intrabdominal surgery, following the conventional perioperative care.
Interventions
Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.
Nasogastric tube until bowel function, late oral eating, opioid analgesics.
Eligibility Criteria
You may qualify if:
- Elective surgery
- ASA grade \< 4
You may not qualify if:
- Emergency surgery
- ASA grade \> 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Andrew General Hospital, Department of Surgery
Pátrai, 26441, Greece
Related Publications (1)
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.
PMID: 19841366RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 20, 2011
First Posted
July 22, 2011
Study Start
October 1, 2010
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
July 22, 2011
Record last verified: 2010-08