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NCT Number: NCT04201730

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

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.

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Key information

Conditions

Enhanced Recovery After Surgery Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Hospitalization Days

    Time frame: Postoperative up to 2 weeks

  2. Time of getting out of bed after operation

    Time frame: Postoperative 7 days

  3. The time to first flatus

    Time frame: Postoperative 7 days

Secondary outcomes

  1. Expenses on medical treatment, medicine and hospitalization

    Time frame: On discharge, Postoperative up to 2 weeks

  2. Incidence of postoperative complications

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

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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