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

Stomach Neoplasms Clinical Trial

Official title:

Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03016026
• Other study ID #: ERAS-LAG-01
• Status: Recruiting
• Phase: Phase 2
• First received: November 24, 2016
• Last updated: January 9, 2017
• Start date: November 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Guoxin Li, MD.,Ph.D
• Phone: +86-138-0277-1450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• ERAS
Undergo an ERAS program

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hospital stays	Days from surgery to discharge	1 month	No
Primary	Rehabilitative rate	Postoperative 4 days	4 days	No
Secondary	Medical cost	From surgery to discharge	1 month	No
Secondary	Postoperative pain score	Postoperative 4 days	4 days	No
Secondary	Postoperative recovery index		1 month	No
Secondary	Postoperative inflammatory immune response	Postoperative 4 days	4 days	No
Secondary	Morbidity rates		30 days	Yes
Secondary	Mortality rates		30 days	Yes