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

N/ACompletedNCT04201730

Huashan Hospital356 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

356

Conditions

Enhanced Recovery After Surgery Gastrointestinal Cancer

Interventions

Enhanced Recovery After Surgery （ERAS）PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hospitalization Days

Time frame: Postoperative up to 2 weeks

Time of getting out of bed after operation

Time frame: Postoperative 7 days

The time to first flatus

Time frame: Postoperative 7 days

Secondary Outcomes

Expenses on medical treatment, medicine and hospitalization

Time frame: On discharge, Postoperative up to 2 weeks

Incidence of postoperative complications

Time frame: Postoperative 3 months、6 months、1 year