Gastric Cancer
Conditions
Brief summary
Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.
Detailed description
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.
Interventions
PROCEDUREERAS group
ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.
PROCEDURESC group
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.
Sponsors
JIANG Zhi-Wei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a parallel, open-label randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative length of stay | 1 month | Postoperative length of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 2 months | Postoperative complications |
| The time to first flatus | 1 week | Bowel recovery |
| Time to semi-liquid diet | 2 week | Bowel recovery |
Countries
China
Outcome results
None listed