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

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ClinicalTrials.gov Identifier: NCT00498290
Recruitment Status : Unknown
Verified March 2009 by Fudan University.
Recruitment status was:  Recruiting
First Posted : July 10, 2007
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Colorectal Surgery Procedure: enhanced recovery after surgery (ERAS) protocol Procedure: control

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery
Study Start Date : September 2006
Primary Completion Date : February 2009
Estimated Study Completion Date : March 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: A
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
No Intervention: B
normal recovery protocol in colorectal surgery
Procedure: control
normal recovery protocol as usually


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: xu jianmin, department of general surgery, zhongshan hospital, fudan university
ClinicalTrials.gov Identifier: NCT00498290     History of Changes
Other Study ID Numbers: 2006-51
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

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