Compliance to ERAS After Gastric Surgery
ERAS
Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma
1 other identifier
interventional
168
1 country
1
Brief Summary
The purpose of this study is to prospectively evaluate the overall compliance to the enhanced recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 13, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 2, 2016
February 1, 2016
1.6 years
July 13, 2012
February 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall compliance to the ERAS program
Patient's compliance to the 18 main elements of ERAS program
90 days
Secondary Outcomes (3)
Morbidity
90 days
Hospital stay
90 days
Mortality
90 days
Study Arms (1)
Enhanced recovery after surgery
EXPERIMENTALPatients who receive ERAS program after gastric cancer surgery
Interventions
The main 18 elements of ERAS program included are described in detail in the brief summary of the study
Eligibility Criteria
You may qualify if:
- Patients who are to undergo gastric cancer surgery
- ASA score \< 3
- ECOG performance status 0-1
- Adequate hepatic, renal, and hematologic function
- Written informed consent
You may not qualify if:
- Previous abdominal operation history
- Concommitant other organ malignant disease
- Preoperative chemotherapy or radiation therapy
- Concommitant other organ resection during surgery
- Emergency operation due to bleeding or perforation
- Active underlying medical illness
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chonnam Nationl University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 519-809, South Korea
Related Publications (1)
Jung MR, Ryu SY, Park YK, Jeong O. Compliance with an Enhanced Recovery After a Surgery Program for Patients Undergoing Gastrectomy for Gastric Carcinoma: A Phase 2 Study. Ann Surg Oncol. 2018 Aug;25(8):2366-2373. doi: 10.1245/s10434-018-6524-4. Epub 2018 May 22.
PMID: 29789971DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Kyu Park, MD, PhD
Chonnam National University Hospital, Korea
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
- Professor, Department of Gastroenterologic Surgery
Study Record Dates
First Submitted
July 13, 2012
First Posted
July 31, 2012
Study Start
July 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 2, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share