Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

September 19, 2021 updated by: Jianbin Xiang, Huashan Hospital

A Single Center, Open, Randomized Clinical Trial：Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

At present, there are more and more reports about enhanced recovery after surgery（ERAS）in China, but there is no ERAS treatment standard for gastrointestinal cancer, and there are many factors limiting the development of ERAS. In recent years, due to the development of minimally invasive technology, the establishment of evidence-based medicine model and the development of MDT, it makes a good solid foundation for the clinical application of ERAS. The implementation of ERAS requires the cooperation of surgeons, anesthesia management, nursing, rehabilitation and other teams. As an individualized treatment mode, ERAS focuses on the optimization of treatment for different individuals in order to acquire the best benefit of patients. Therefore, the concept of ERAS is still in the process of continuous improvement and development in China, hoping to explore the Chinese ERAS clinical pathway for gastrointestinal cancer. The purpose of this study is to optimize the clinical pathway of ERAS in the perioperative period of gastrointestinal cancer, and to evaluate the effectiveness and safety of ERAS in gastrointestinal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200040
        • Huashan Hospital affiliated to Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sign the informed consent
  • Preoperative pathology confirmed gastric cancer or colorectal cancer
  • Age: 18-70 years, men or women
  • According to NCCN guidelines, it is not Stage IV tumor
  • Perform radical gastrectomy or radical colon cancer surgery (CME) or radical rectal cancer surgery (TME);
  • ASA I-III
  • Receive no radiotherapy or chemotherapy before operation
  • The subjects can describe the symptoms objectively and keep the follow-up plan

Exclusion Criteria:

  • Preoperative pathology confirmed no gastric cancer / no colorectal cancer (such as rectal neuroendocrine tumor, lymphoma, etc.)
  • Stage IV or Radical resection can't be performed
  • Emergency operation
  • Can't cooperate with clinical data collection
  • General condition is intolerable to operation
  • Serious diseases, including heart function ≥ level II, respiratory function insufficiency, liver and kidney function insufficiency, and blood system diseases
  • Patients participate in other clinical trials at the same time
  • Pregnant or perinatal women
  • Other malignant tumors
  • History of mental illness
  • Had a history of severe trauma within 4 weeks before admission
  • Less than 6 months after other level 4 operations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS
Perioperative intervention with individual Enhanced Recovery After Surgery （ERAS）
Procedure: Enhanced Recovery After Surgery （ERAS）
Preoperative education，Preoperative nutritional support，Preoperative bowel preparation，Preventative applying of antibiotics，Intraoperative warming，Goal-directed fluid therapy，Postoperative analgesia，Postoperative diet, drainage and activity management，Prevention of deep vein thrombosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospitalization Days
Time Frame: Postoperative up to 2 weeks
Postoperative up to 2 weeks
Time of getting out of bed after operation
Time Frame: Postoperative 7 days
Postoperative 7 days
The time to first flatus
Time Frame: Postoperative 7 days
Postoperative 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Expenses on medical treatment, medicine and hospitalization
Time Frame: On discharge, Postoperative up to 2 weeks
On discharge, Postoperative up to 2 weeks
Incidence of postoperative complications
Time Frame: Postoperative 3 months、6 months、1 year
Postoperative 3 months、6 months、1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 14, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 19, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2018-396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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