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Clinical Trials/NCT00498290
NCT00498290UnknownNot Applicable

The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery

Fudan University1 site in 1 country500 target enrollmentStarted: September 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
500
Locations
1
Primary Endpoint
safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
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

Arms & Interventions

A

Experimental

received enhanced recovery after surgery (ERAS) protocol in colorectal surgery

Intervention: enhanced recovery after surgery (ERAS) protocol (Procedure)

B

No Intervention

normal recovery protocol in colorectal surgery

Intervention: control (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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