NCT00498290

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

2.4 years

First QC Date

July 9, 2007

Last Update Submit

March 24, 2009

Conditions

Colorectal Surgery

Keywords

Enhanced Recovery After Surgery Protocol(ERAS)Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

A

EXPERIMENTAL

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

Procedure: enhanced recovery after surgery (ERAS) protocol

B

NO INTERVENTION

normal recovery protocol in colorectal surgery

Procedure: control

Interventions

enhanced recovery after surgery (ERAS) protocolPROCEDURE

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

A
controlPROCEDURE

normal recovery protocol as usually

B

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal surgery patients
  • Age 20～80
  • Without comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction

You may not qualify if:

  • Emergency
  • Combined other organ resection
  • Age \> 80
  • Comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22102090DERIVED

MeSH Terms

Interventions

Enhanced Recovery After SurgeryClinical Protocols

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, OperativeTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • jianmin xu, professor

    department of general surgery, zhongshan hospital, fudan university

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

September 1, 2006

Primary Completion

February 1, 2009

Study Completion

March 1, 2010

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

CN(1)