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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016026
Recruitment Status : Unknown
Verified January 2017 by Guoxin Li, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Guoxin Li, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE November 24, 2016
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date January 10, 2017
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stomach Neoplasms
Intervention  ICMJE Procedure: ERAS
Undergo an ERAS program
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 9, 2017)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03016026
Other Study ID Numbers  ICMJE ERAS-LAG-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guoxin Li, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP