Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins (ERASAG)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
conventional pathway group
conventional pathway group
conventional pathway group
conventional pathway group
conventional pathway group
conventional pathway group
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Enhanced recovery after surgery, laparoscopic gastrectomy, advanced gastric cancer, C-reactive,visceral proteins
Eligibility Criteria
Inclusion Criteria:
- Age 18-75 years old
- Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
- No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
- No neoadjuvant chemotherapy and radiotherapy
- No digestive obstruction and distant metastasis
Exclusion Criteria:
- Conversion to open gastrectomy
- A large amount of bleeding leading(>500ml)
- Patients withdrew their consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ERAS group
conventional pathway group
Arm Description
ERAS protocols
using conventional pathway
Outcomes
Primary Outcome Measures
Compartition of postoperative hospital stay
Secondary Outcome Measures
Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
1day before and 1-5days after operation
Full Information
NCT ID
NCT02348229
First Posted
January 17, 2015
Last Updated
January 27, 2015
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT02348229
Brief Title
Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins
Acronym
ERASAG
Official Title
Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins in Patients With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.
Detailed Description
Enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. Recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Enhanced recovery after surgery, laparoscopic gastrectomy, advanced gastric cancer, C-reactive,visceral proteins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERAS group
Arm Type
Experimental
Arm Description
ERAS protocols
Arm Title
conventional pathway group
Arm Type
Other
Arm Description
using conventional pathway
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
No bowel preparation
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
No nasogastric placement; if used, remove on the 1st postoperative day
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
Vasoactive drugs used if need be
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
Temperature management
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
Intra-abdominal drains not to be used
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
Intraperitoneal Ropivicaine infusion
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
On the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed.
Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
On the 2nd postoperative day:Drains removed Oral diet was initiated
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
3-4th postoperative day: Stop oral non opioid analgesia
Intervention Type
Procedure
Intervention Name(s)
ERAS protocols
Intervention Description
On the5-6th postoperative day Check discharge criteria
Intervention Type
Procedure
Intervention Name(s)
conventional pathway group
Intervention Description
No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery
Intervention Type
Procedure
Intervention Name(s)
conventional pathway group
Intervention Description
Routine use of anesthesia medicine. Standard 5-trocar laparoscopy-assisted procedure. I.V. fluids not restricted (Ringer's lactate 20 ml/kg in the first hour, then at the rate of 10-12 ml/kg/h) Routine use of abdominal drainage tubes and placement of catheters.
Intervention Type
Procedure
Intervention Name(s)
conventional pathway group
Intervention Description
1st postoperative day: Keep Nasogastric catheter Removal of urinary catheter Opioid analgesic by intramuscular injection Parenteral nutrition until flatus. I.V. fluids not restricted Mobilization in bed
Intervention Type
Procedure
Intervention Name(s)
conventional pathway group
Intervention Description
2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery
Intervention Type
Procedure
Intervention Name(s)
conventional pathway group
Intervention Description
3-4th postoperative day: Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.
Intervention Type
Procedure
Intervention Name(s)
conventional pathway group
Intervention Description
5-6th postoperative day:Oral diet was changed from liquids to semi-fluids and normal food.
Drains removed
Primary Outcome Measure Information:
Title
Compartition of postoperative hospital stay
Time Frame
up to 30 days after the operation
Secondary Outcome Measure Information:
Title
Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 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 18-75 years old
Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
No neoadjuvant chemotherapy and radiotherapy
No digestive obstruction and distant metastasis
Exclusion Criteria:
Conversion to open gastrectomy
A large amount of bleeding leading(>500ml)
Patients withdrew their consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Wang, Doctor
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
27875094
Citation
Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.
Results Reference
derived
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Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins
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