Enhanced Recovery After Surgery Program for Gastric Cancer: a Multi-center Study (ERASG1)

Jinling Hospital, China

Status: Unknown

Conditions: Gastric Cancer

Treatments: Procedure: enhanced recovery after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03121729

BE2015687

Details and patient eligibility

About

This study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.

Full description

In China, gastric cancer results in the second highest morbidity and mortality rates among all malignancies. It is very important for treatment of gastric cancer to enhance the quality of treatment, increase patients' survival rate and improve the life quality. Now, "Gastric Cancer, Version 3.2016, NCCN Clinical Practice Guidelines in Oncology" and "Japanese gastric cancer treatment guidelines 2014 (ver. 4)" recommended surgical resection for gastric cancer. As a result, increasing the quality of surgery and improving the perioperative measures have a great influence on patients received a gastrectomy. Before, patients discharged on 7-10 days after gastrectomy and recovered 4-8 weeks after surgery. So, it is significant for patients to recover from surgical trauma in order to receive other anti-cancer therapies after gastrectomy. Investigators spent over ten years studying enhanced recovery after surgery programs for gastric cancer and have got some successful experience. Investigators found enhanced recovery after surgery can accelerate patients' recovery without increasing complications.

This study is the first multi-center study of enhanced recovery after surgery for gastric cancer all over the world. During this period, the study is aimed to evaluate the safety of applying enhanced recovery after surgery for gastric cancer.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Requirements of informed consent and assent of participant, parent or legal guardian as applicable
2. Patients with gastric cancer scheduled for radical gastrectomy and between the age of 18 and 75 years old without considering sex
3. ASA physical status I-III
4. Participants can follow the drug doses and visit plan

Exclusion criteria

1. Patients certified by a doctor that doesn't fit to participate in this study.
2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function > II (NYHA) patients, patients received CABG recently, and patients with severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).
3. Patients with gastric cancer with distant metastasis.
4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance < 25 ml/min).
5. Patients allergic to common drugs, such as opioids, non-steroidal drugs, cephalosporins, etc.
6. Patients with operations of gastrointestinal cancer and complicated abdominal operations.
7. Patients complicated by gastric cancer with complications such as hemorrhage, perforation, obstruction.
8. Patients with dyscrasia and severe malnutrition (albumin≤30g/L, weight loss in half a year>10%, SGA classification C, BMI<18, Hb<70g/L).
9. Patients with metabolic complications caused by diabetes.
10. Patients can't finish enhanced recovery after surgery programs and have contraindications of enhanced recovery after surgery.
11. Pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants).
12. Patients participated other subjects 3 months before this subject.
13. Sponsors or researchers directly involved in the testing or their family members.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

enhanced recovery after surgery

Experimental group

Description:

enhanced recovery after surgery includes: 1. Multimodal analgesia 2. Early oral intake A: Drink water after anesthetic awareness. B: Recover semi-liquid diet 3. Management of nasogastric tube and catheter A: Not indwell nasogastric tube conventionally B: Remove catheter early 4. Early activity 5. Perioperative controlled infusion A: Load carbohydrate preoperatively B: No preoperative bowel preparation C: Fast six hours before surgery, no drink two hours before surgery D: Intraoperative liquid management: 3-6ml/kg/h, determined by anesthetists E: Stop intravenous infusion upon 2000-2500ml water and semiliquid diet being taken

Treatment:

Procedure: enhanced recovery after surgery