The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery (ERAS)
Recruitment status was Recruiting
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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 |
- 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 |
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| 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 | |
| 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 May 23, 2013