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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

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: ERAS Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial
Study Start Date : November 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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.
Procedure: ERAS
Undergo an ERAS program




Primary Outcome Measures :
  1. Postoperative hospital stays [ Time Frame: 1 month ]
    Days from surgery to discharge

  2. Rehabilitative rate [ Time Frame: 4 days ]
    Postoperative 4 days


Secondary Outcome Measures :
  1. Medical cost [ Time Frame: 1 month ]
    From surgery to discharge

  2. Postoperative pain score [ Time Frame: 4 days ]
    Postoperative 4 days

  3. Postoperative recovery index [ Time Frame: 1 month ]
  4. Postoperative inflammatory immune response [ Time Frame: 4 days ]
    Postoperative 4 days

  5. Morbidity rates [ Time Frame: 30 days ]
  6. Mortality rates [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016026


Contacts
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Contact: Guoxin Li, MD.,Ph.D +86-138-0277-1450 gzliguoxin@163.com
Contact: Hao Liu, MD.,Ph.D +86-138-2215-8578 283934099@qq.com

Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510-515
Contact: Guoxin Li, M.D., Ph.D.    +86-138-0277-1450    gzliguoxin@163.com   
Contact: Yu Zhu, M.D.    +86-135-6022-0055    283934099@qq.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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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
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Responsible Party: Guoxin Li, M.D.,Ph.D., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03016026    
Other Study ID Numbers: ERAS-LAG-01
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Guoxin Li, Nanfang Hospital of Southern Medical University:
ERAS,Laparoscopy,Distal Gastrectomy,Safety,Effectiveness
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases