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The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery (ERAS)

This study is currently recruiting participants.
Verified by Fudan University, March 2008

Sponsored by: Fudan University
Information provided by: Fudan University
ClinicalTrials.gov Identifier: NCT00498290
  Purpose

The purpose of this study is to determine whether ERAS is safe and can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery.


Condition Intervention
Colorectal Surgery
Procedure: enhanced recovery after surgery(ERAS) protocol
Procedure: control

MedlinePlus related topics:   Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery [ Time Frame: perioperation and until 30 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   500
Study Start Date:   September 2006
Estimated Study Completion Date:   July 2008
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
received enhanced recovery after surgery(ERAS) protocol in colorectal surgery
Procedure: enhanced recovery after surgery(ERAS) protocol
An integrated protocol aims to allow patients to recover more quickly from major surgery, avoid medium-term sequelae of conventional postoperative care (e.g. decline in nutritional status and fatigue) and reduce health care costs by reducing hospital stay
B: No Intervention
normal recovery protocol in colorectal surgery
Procedure: control
normal recovery protocol as usually

Detailed Description:

The key factors that keep a patient in hospital after uncomplicated major colorectal surgery include the need for parenteral analgesia(persistent pain), intravenous fluids (persistent gut dysfunction), and bed rest (persistent lack of mobility). These factors often overlap and interact to delay return of function. Obviously, postoperative complications will also prolong the time until recovery and ultimately length of stay. A clinical pathway, called Enhanced Recovery After Surgery(ERAS), to accelerate recovery after colonic resection based on a multimodal programme with optimal pain relief, stress reduction with regional anaesthesia, early enteral nutrition and early mobilisation has demonstrated improvements in physical performance, pulmonary function, body composition and a marked reduction of length of stay.

Comparison(s): A total of 500 cases colorectal surgery were randomized to receive ERAS protocol or the traditional protocol, such as mechanical bowl preparation, intravenous fluids until bowl movement recovery and bed rest.

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Colorectal surgery patients
  • Age 20~80
  • Without comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction

Exclusion Criteria:

  • Emergency
  • Combined other organ resection
  • Age > 80
  • Comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498290

Locations
China
Department of General Surgery, Zhongshan Hospital, Fudan University     Recruiting
      shanghai, China, 200032
      Contact: jianmin xu, professor     008613501984869     xujmin@yahoo.com.cn    
      Contact: yunshi zhong, doctor     008613564623481     zhong780124@sina.com    

Sponsors and Collaborators
Fudan University

Investigators
Study Chair:     jianmin xu, professor     department of general surgery, zhongshan hospital, fudan university    
  More Information


Responsible Party:   department of general surgery, zhongshan hospital, fudan university ( xu jianmin )
Study ID Numbers:   2006-51
First Received:   July 9, 2007
Last Updated:   March 21, 2008
ClinicalTrials.gov Identifier:   NCT00498290
Health Authority:   China: Ethics Committee

Keywords provided by Fudan University:
Enhanced Recovery After Surgery Protocol(ERAS)  
Colorectal Surgery  

ClinicalTrials.gov processed this record on October 06, 2008




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