Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins
ERASAG
1 other identifier
interventional
149
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Sep 2013
Shorter than P25 for not_applicable gastric-cancer
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
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 17, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedJanuary 28, 2015
January 1, 2015
1 year
January 17, 2015
January 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compartition of postoperative hospital stay
up to 30 days after the operation
Secondary Outcomes (1)
Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
baseline and 5 days
Study Arms (2)
ERAS group
EXPERIMENTALERAS protocols
conventional pathway group
OTHERusing conventional pathway
Interventions
Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery
No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Conversion to open gastrectomy
- A large amount of bleeding leading(\>500ml)
- Patients withdrew their consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27875094DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Quan Wang, Doctor
The First Hospital of Jilin University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2015
First Posted
January 28, 2015
Study Start
September 1, 2013
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
January 28, 2015
Record last verified: 2015-01