ERAS for Patients Received Neoadjuvant Chemotherapy

Not Applicable

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: ERAS group; Procedure: SC group

• Registration Number: NCT03272984
• Lead Sponsor: JIANG Zhi-Wei

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.

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2017-06-05
• Study Completion: 2017-07-06
• Status Verified: 2017-09
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-04
• Last Update Submitted: 2017-09-05
• Study First Posted: 2017-09-06
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	ERAS group	Patients will undergo the ERAS programs.
SC group	SC group	Patients will undergo the SC group.

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay	1 month	Postoperative length of stay

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	2 months	Postoperative complications
The time to first flatus	1 week	Bowel recovery
Time to semi-liquid diet	2 week	Bowel recovery

Trial Locations

Locations (1)

Jinling Hospital, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China