ERAS for Patients Received Neoadjuvant Chemotherapy

JIANG Zhi-Wei114 enrolled

Overview

Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.

Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Gastric Cancer

Interventions

ERAS groupPROCEDURE

ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.

SC groupPROCEDURE

Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients received neoadjuvant chemotherapy with locally advanced gastric cancer. 2. Age older than 18 and younger than 75 years. 3. American Society of Anesthesiologists (ASA) class: I-III. 4. Participants can describe the symptom objectively and cooperate actively. 5. Written informed consent. Exclusion Criteria: 1. Patients allergic to oxaliplatin, tegafur gimerac etc. 2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function \> II (NYHA) 3. Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer. 4. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr \< 25 ml/min). 5. Patients who require simultaneous surgery for other diseases. 6. Patients who received upper abdominal surgery previously. 7. Pregnant or breast-feeding women.

Locations (1)

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Postoperative length of stay

Time frame: 1 month

Secondary Outcomes

Postoperative complications

Time frame: 2 months

The time to first flatus

Bowel recovery

Time frame: 1 week

Time to semi-liquid diet

Bowel recovery

Time frame: 2 week

Data from ClinicalTrials.gov

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