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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04201730
Enrollment
356
Registered
2019-12-17
Start date
2019-12-25
Completion date
2021-06-01
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhanced Recovery After Surgery, Gastrointestinal Cancer

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.

Interventions

PROCEDUREEnhanced 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.

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Hospitalization DaysPostoperative up to 2 weeks
Time of getting out of bed after operationPostoperative 7 days
The time to first flatusPostoperative 7 days

Secondary

MeasureTime frame
Expenses on medical treatment, medicine and hospitalizationOn discharge, Postoperative up to 2 weeks
Incidence of postoperative complicationsPostoperative 3 months、6 months、1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026