Clinical trial NCT00498290: The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery
Official title: The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Surgery
Keywords: Enhanced Recovery After Surgery Protocol(ERAS)
Colorectal Surgery
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2007-07-10
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery
timeFrame: perioperation and until 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of General Surgery, Zhongshan Hospital, Fudan University
Study officials:
affiliation: department of general surgery, zhongshan hospital, fudan university
name: jianmin xu, professor
role: STUDY_CHAIR
References:
citation: Ren L, Zhu D, Wei Y, Pan X, Liang L, Xu J, Zhong Y, Xue Z, Jin L, Zhan S, Niu W, Qin X, Wu Z, Wu Z. Enhanced Recovery After Surgery (ERAS) program attenuates stress and accelerates recovery in patients after radical resection for colorectal cancer: a prospective randomized controlled trial. World J Surg. 2012 Feb;36(2):407-14. doi: 10.1007/s00268-011-1348-4.