The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery

Not Applicable

• Conditions: Colorectal Surgery
• Interventions: Procedure: enhanced recovery after surgery (ERAS) protocol; Procedure: control

• Registration Number: NCT00498290
• Lead Sponsor: Fudan University

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Primary Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	enhanced recovery after surgery (ERAS) protocol	received enhanced recovery after surgery (ERAS) protocol in colorectal surgery
B	control	normal recovery protocol in colorectal surgery

Primary Outcome Measures

Name	Time	Method
safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery	perioperation and until 30 days after surgery

Trial Locations

Locations (1)

Department of General Surgery, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China