Clinical trial NCT04201730: Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer
Official title: A Single Center, Open, Randomized Clinical Trial：Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhanced Recovery After Surgery
Gastrointestinal Cancer
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization Days
timeFrame: Postoperative up to 2 weeks
measure: Time of getting out of bed after operation
timeFrame: Postoperative 7 days
measure: The time to first flatus
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: Expenses on medical treatment, medicine and hospitalization
timeFrame: On discharge, Postoperative up to 2 weeks
measure: Incidence of postoperative complications
timeFrame: Postoperative 3 months、6 months、1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
References:
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