Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status
The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
1 other identifier
interventional
1,400
0 countries
N/A
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.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications 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 Mar 2017
Longer than P75 for not_applicable
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 3, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFebruary 6, 2017
February 1, 2017
4 years
February 2, 2017
February 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complication
fever；wound infection；post-operation bleeding；ileus；stenosis；leakage
30 days after operation
Study Arms (2)
Preoperational nutrition support group
EXPERIMENTALScored patient-generated subjective global assessment(PG-SGA) ≥2，\<9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
Conventional group
NO INTERVENTIONPG-SGA ≥2，\<9
Interventions
Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
Eligibility Criteria
You may qualify if:
- 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;
- age 18-75 years;
- pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;
- normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score \< III without severe systemic disease;
- no history of treatment with neoadjuvant chemotherapy and/or radiotherapy
- PG-SGA score ≥2，\<9
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 3, 2017
Study Start
March 1, 2017
Primary Completion
March 1, 2021
Study Completion
September 30, 2021
Last Updated
February 6, 2017
Record last verified: 2017-02