Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 2

Conditions: Stomach Neoplasms

Treatments: Procedure: ERAS

Study type: Interventional

Funder types: Other

Identifiers

NCT03016026

ERAS-LAG-01

Details and patient eligibility

About

This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS program.

Full description

Preoperative education about ERAS program is administered in the ward after admission by a specific team. Breathing training and atomizing during the time of preoperative preparation is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10% carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation is not recommended as routine procedure.

The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns of surgical safety). Surgical site infiltration is implemented.All patients undergo laparoscopic distal gastrectomy.

Urinary catheters are routinely removed within 24 hours after operation. An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on POD 4. Abdominal drains are routinely removed within 72 hours after operation.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from over 18 to under 75 years
• Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
• cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
• Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
• no severe organ dysfunction
• Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
• ASA (American Society of Anesthesiology) score class I or II
• Written informed consent

Exclusion criteria

• Women during pregnancy or breast-feeding
• Severe mental disorder
• History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
• Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
• History of other malignant disease within past five years
• History of previous neoadjuvant chemotherapy or radiotherapy
• History of unstable angina or myocardial infarction within past six months
• History of cerebrovascular accident within past six months
• History of continuous systematic administration of corticosteroids within one month
• Requirement of simultaneous surgery for other disease
• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
• FEV1<50% of predicted values

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

ERAS

Experimental group

Description:

Preoperative education,breathing training and atomizing during the time of preoperative preparation.Shorten fasting time and carbohydrate load.The intravenous fluid therapy is restricted.Drainage and nasogastric tube are not placed (except the concerns of surgical safety).All patients undergo laparoscopic distal gastrectomy.An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia.Early oral take and move.

Treatment:

Procedure: ERAS