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

Not Applicable

Completed

• Conditions: Enhanced Recovery After Surgery; Gastrointestinal Cancer
• Interventions: Procedure: Enhanced Recovery After Surgery （ERAS）

• Registration Number: NCT04201730
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-14
• Study First Posted: 2019-12-17
• Study Start: 2019-12-25
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-19
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERAS	Enhanced Recovery After Surgery （ERAS）	Perioperative intervention with individual Enhanced Recovery After Surgery （ERAS）

Primary Outcome Measures

Name	Time	Method
Time of getting out of bed after operation	Postoperative 7 days
Hospitalization Days	Postoperative up to 2 weeks
The time to first flatus	Postoperative 7 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Huashan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, China