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Sponsored by: |
Fudan University |
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Information provided by: | Fudan University |
ClinicalTrials.gov Identifier: | NCT00498290 |
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 |
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Colorectal Surgery |
Procedure: enhanced recovery after surgery (ERAS) protocol Procedure: control |
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 |
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 |
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A: Experimental
received enhanced recovery after surgery (ERAS) protocol in colorectal surgery
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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
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B: No Intervention
normal recovery protocol in colorectal surgery
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Procedure: control
normal recovery protocol as usually
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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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | department of general surgery, zhongshan hospital, fudan university ( xu jianmin ) |
Study ID Numbers: | 2006-51 |
Study First Received: | July 9, 2007 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00498290 History of Changes |
Health Authority: | China: Ethics Committee |
Enhanced Recovery After Surgery Protocol(ERAS) Colorectal Surgery |