Enhanced Recovery After Surgery in Major Intrabdominal Procedures.

Complication of Surgical and Medical Care. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400711
• Other study ID #: 1VA
• Status: Completed
• Phase: N/A
• First received: June 20, 2011
• Last updated: July 21, 2011
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: August 2010
• Source: St. Andrew's General Hospital, Patras, Greece
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 89 Years

Eligibility

Inclusion Criteria:

• Elective surgery

• ASA grade < 4

Exclusion Criteria:

• Emergency surgery

• ASA grade > 3

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Surgical and Medical Care.

Intervention

Other:
• ERAS perioperative care
Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.
• Traditional
Nasogastric tube until bowel function, late oral eating, opioid analgesics.

Locations

Country	Name	City	State
Greece	St. Andrew General Hospital, Department of Surgery	Patra

Sponsors (1)

Lead Sponsor	Collaborator
St. Andrew's General Hospital, Patras, Greece

Country where clinical trial is conducted

Greece, 

References & 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 surg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity.		30 days after surgery	No
Secondary	Mortality.		30 days after surgery	No