NCT02728973

Brief Summary

Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. The purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. The investigators plan to compare the feasibility, clinical effectiveness, and cost savings of an ERAS program with traditional treatment program at a major teaching hospital in China.The investigators will apply ERAS plan or traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively. And data Compare the two programs about the incidence of postoperative complications, postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 27, 2016

Last Update Submit

March 31, 2016

Conditions

Postoperative Complications

Keywords

colorectal resectionenhanced recovery after surgeryPostoperative Complicationslength of hospital stay

Outcome Measures

Primary Outcomes (1)

  • The difference in postoperative morbidity rate

    within postoperative 30 days

Secondary Outcomes (2)

  • length of hospital stay

    within postoperative 30 days

  • mortality

    within postoperative 30 days

Study Arms (2)

ERAS program

The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period.

Other: ERAS program

conventional treatment program

conventional treatment

Interventions

ERAS programOTHER

The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period.

ERAS program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receive elective laparotomy or laparoscopic intestinal surgery

You may qualify if:

  • Elective laparotomy or laparoscopic intestinal surgery.
  • Age ≥ 18 years old.
  • ASA grade II - IV.
  • General anesthesia.

You may not qualify if:

  • Patients with cognitive dysfunction and uncooperative subjects.
  • Failure to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Related Publications (1)

  • Peng LH, Min S, Jin JY, Wang WJ. Stratified pain management counseling and implementation improving patient satisfaction: a prospective, pilot study. Chin Med J (Engl). 2019 Dec 5;132(23):2812-2819. doi: 10.1097/CM9.0000000000000540.

    PMID: 31856052DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Su Min, MD

    First Affiliated Hospital of Chongqing Medical University

    STUDY CHAIR

Central Study Contacts

Juying Jin, doctor

CONTACT

+89-13527486171juyingjin@hotmail.com

Su Min, MD

CONTACT

+86-89011068ms89011068@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 6, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

April 6, 2016

Record last verified: 2016-03

Locations

CN(1)