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

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ERAS
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring ERAS,Laparoscopy,Distal Gastrectomy,Safety,Effectiveness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERAS

Arm Description

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.

Outcomes

Primary Outcome Measures

Postoperative hospital stays
Days from surgery to discharge
Rehabilitative rate
Postoperative 4 days

Secondary Outcome Measures

Medical cost
From surgery to discharge
Postoperative pain score
Postoperative 4 days
Postoperative recovery index
Postoperative inflammatory immune response
Postoperative 4 days
Morbidity rates
Mortality rates

Full Information

First Posted
November 24, 2016
Last Updated
January 9, 2017
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03016026
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
ERAS,Laparoscopy,Distal Gastrectomy,Safety,Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERAS
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
ERAS
Intervention Description
Undergo an ERAS program
Primary Outcome Measure Information:
Title
Postoperative hospital stays
Description
Days from surgery to discharge
Time Frame
1 month
Title
Rehabilitative rate
Description
Postoperative 4 days
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Medical cost
Description
From surgery to discharge
Time Frame
1 month
Title
Postoperative pain score
Description
Postoperative 4 days
Time Frame
4 days
Title
Postoperative recovery index
Time Frame
1 month
Title
Postoperative inflammatory immune response
Description
Postoperative 4 days
Time Frame
4 days
Title
Morbidity rates
Time Frame
30 days
Title
Mortality rates
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoxin Li, MD.,Ph.D
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Liu, MD.,Ph.D
Phone
+86-138-2215-8578
Email
283934099@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, MD.,Ph.D
Organizational Affiliation
Southern Medical University, Guangzhou,China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kexuan Liu, MD.,Ph.D
Organizational Affiliation
Southern Medical University, Guangzhou,China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hao Liu, MD.,Ph.D
Organizational Affiliation
Southern Medical University, Guangzhou,China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Li Zhen, MD.,Ph.D
Organizational Affiliation
Southern Medical University, Guangzhou,China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xiaomin Hou, MD.,Ph.D
Organizational Affiliation
Southern Medical University, Guangzhou,China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jiang Yu, MD.,Ph.D
Organizational Affiliation
Southern Medical University, Guangzhou,China
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yu Zhu, MD.
Organizational Affiliation
MD.,Ph.D
Official's Role
Study Director
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name & Degree
Yu Zhu, M.D.
Phone
+86-135-6022-0055
Email
283934099@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33607765
Citation
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.
Results Reference
derived

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

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