Clinical trial NCT03272984: ERAS for Patients Received Neoadjuvant Chemotherapy
Official title: Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel, open-label randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative length of stay
timeFrame: 1 month
Secondary outcomes:
measure: Postoperative complications
timeFrame: 2 months
measure: The time to first flatus
timeFrame: 1 week
measure: Time to semi-liquid diet
timeFrame: 2 week
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Zhiwei JIANG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jian ZHAO, MD
role: STUDY_DIRECTOR
References: