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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00498290
First received: July 9, 2007
Last updated: March 24, 2009
Last verified: March 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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: March 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

No publications provided by Fudan University

Additional 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
Study First Received: July 9, 2007
Last Updated: March 24, 2009
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014