Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy
Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 24, 2016
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJanuary 10, 2017
January 1, 2017
1.6 years
November 24, 2016
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative hospital stays
Days from surgery to discharge
1 month
Rehabilitative rate
Postoperative 4 days
4 days
Secondary Outcomes (6)
Medical cost
1 month
Postoperative pain score
4 days
Postoperative recovery index
1 month
Postoperative inflammatory immune response
4 days
Morbidity rates
30 days
- +1 more secondary outcomes
Study Arms (1)
ERAS
EXPERIMENTALPreoperative 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515, China
Related Publications (1)
Liang Y, Liu H, Nurse LZ, Zhu Y, Zhao M, Hu Y, Yu J, Li C, Liu K, Li G. Enhanced recovery after surgery for laparoscopic gastrectomy in gastric cancer: A prospective study. Medicine (Baltimore). 2021 Feb 19;100(7):e24267. doi: 10.1097/MD.0000000000024267.
PMID: 33607765DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.,Ph.D.
Study Record Dates
First Submitted
November 24, 2016
First Posted
January 10, 2017
Study Start
November 1, 2016
Primary Completion
June 1, 2018
Study Completion
July 1, 2018
Last Updated
January 10, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share