Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial
1 other identifier
interventional
400
1 country
1
Brief Summary
This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedStudy Start
First participant enrolled
February 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedFebruary 8, 2017
February 1, 2017
1.1 years
February 2, 2017
February 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical parameters
length of post-operative stay
One week after operation
Secondary Outcomes (1)
Postoperative complications
30 days after operation
Study Arms (2)
ERAS group
EXPERIMENTALPatients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group.
conventional pathway group
NO INTERVENTIONThe conventional pathway group received conventional care.
Interventions
optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization
Eligibility Criteria
You may qualify if:
- (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score \< III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.
You may not qualify if:
- patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Hospital of Jilin University
Changchun, Jilin, 130021, China
Central Study Contacts
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
February 2, 2017
First Posted
February 8, 2017
Study Start
February 20, 2017
Primary Completion
March 30, 2018
Study Completion
January 30, 2019
Last Updated
February 8, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share