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

March 24, 2009 updated by: Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Department of General Surgery, Zhongshan Hospital, Fudan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
perioperation and until 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Chair: jianmin xu, professor, Department of General Surgery, Zhongshan Hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria

July 9, 2007

First Posted (Estimate)

July 10, 2007

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2006-51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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