The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery

NCT ID: NCT00498290

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

enhanced recovery after surgery (ERAS) protocol

Intervention Type PROCEDURE

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

B

normal recovery protocol in colorectal surgery

Group Type NO_INTERVENTION

control

Intervention Type PROCEDURE

normal recovery protocol as usually

Interventions

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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

Intervention Type PROCEDURE

control

normal recovery protocol as usually

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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department of general surgery, zhongshan hospital, fudan university

Principal Investigators

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jianmin xu, professor

Role: STUDY_CHAIR

department of general surgery, zhongshan hospital, fudan university

Locations

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Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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jianmin xu, professor

Role: primary

008613501984869

yunshi zhong, doctor

Role: backup

008613564623481

References

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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.

Reference Type DERIVED
PMID: 22102090 (View on PubMed)

Other Identifiers

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2006-51

Identifier Type: -

Identifier Source: org_study_id

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