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

• ClinicalTrials.gov Identifier: NCT03016026
• Recruitment Status: Unknown
• First Posted: January 10, 2017
• Last Update Posted: January 10, 2017
• Sponsor: Nanfang Hospital of Southern Medical University
• Information provided by (Responsible Party): Guoxin Li, Nanfang Hospital of Southern Medical University

Tracking Information

• First Submitted Date: November 24, 2016
• First Posted Date: January 10, 2017
• Last Update Posted Date: January 10, 2017
• Study Start Date: November 2016
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2017)

• Postoperative hospital stays [ Time Frame: 1 month ]
  Days from surgery to discharge
• Rehabilitative rate [ Time Frame: 4 days ]
  Postoperative 4 days

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 9, 2017)

• Medical cost [ Time Frame: 1 month ]
  From surgery to discharge
• Postoperative pain score [ Time Frame: 4 days ]
  Postoperative 4 days
• Postoperative recovery index [ Time Frame: 1 month ]
• Postoperative inflammatory immune response [ Time Frame: 4 days ]
  Postoperative 4 days
• Morbidity rates [ Time Frame: 30 days ]
• Mortality rates [ Time Frame: 30 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stomach Neoplasms

Intervention

Procedure: ERAS

Undergo an ERAS program

Study Arms

Experimental: ERAS

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.

Intervention: Procedure: ERAS

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 9, 2017): 98
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2018
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03016026
• Other Study ID Numbers: ERAS-LAG-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Guoxin Li, Nanfang Hospital of Southern Medical University
• Study Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Guoxin Li, MD.,Ph.D; Southern Medical University, Guangzhou,China
• Principal Investigator: Kexuan Liu, MD.,Ph.D; Southern Medical University, Guangzhou,China
• Study Director: Hao Liu, MD.,Ph.D; Southern Medical University, Guangzhou,China
• Study Director: Li Zhen, MD.,Ph.D; Southern Medical University, Guangzhou,China
• Study Director: Xiaomin Hou, MD.,Ph.D; Southern Medical University, Guangzhou,China
• Study Director: Jiang Yu, MD.,Ph.D; Southern Medical University, Guangzhou,China
• Study Director: Yu Zhu, MD.; MD.,Ph.D

• PRS Account: Nanfang Hospital of Southern Medical University
• Verification Date: January 2017