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

Sponsor
Huashan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04201730
Collaborator
(none)
356
Enrollment
1
Location
1
Arm
17.2
Actual Duration (Months)
20.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Enhanced Recovery After Surgery （ERAS）
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
356 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Center, Open, Randomized Clinical Trial：Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer
Actual Study Start Date :
Dec 25, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Hospitalization Days [Postoperative up to 2 weeks]

  2. Time of getting out of bed after operation [Postoperative 7 days]

  3. The time to first flatus [Postoperative 7 days]

Secondary Outcome Measures

  1. Expenses on medical treatment, medicine and hospitalization [On discharge, Postoperative up to 2 weeks]

  2. Incidence of postoperative complications [Postoperative 3 months、6 months、1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital Affiliated to Fudan University Shanghai China 200040

Sponsors and Collaborators

  • Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jianbin Xiang, Professor, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT04201730
Other Study ID Numbers:
  • KY2018-396
First Posted:
Dec 17, 2019
Last Update Posted:
Sep 21, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastrointestinal Neoplasms

Study Results

No Results Posted as of Sep 21, 2021