The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy
1 other identifier
observational
310
1 country
1
Brief Summary
The purpose of this study is to explore the effect of preoperative inflammation-based scores on postoperative morbidity and mortality for laparoscopic gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Longer than P75 for all trials
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
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedFebruary 5, 2020
February 1, 2020
1.1 years
September 21, 2016
February 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
3-year disease free survival rate
36 months
Secondary Outcomes (28)
3-year disease overall survival rate
36 months
Morbidity and mortality
30 days; 36 months
3-year recurrence pattern
36 months
Time to first ambulation
10 days
The number of lymph node dissection
1 day
- +23 more secondary outcomes
Eligibility Criteria
Patients who undergoing laparoscopic radical gastrectomy for gastric cancer are included.
You may qualify if:
- Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
You may not qualify if:
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node envelop important vessels
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1\<50% of predicted values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changming Huang, Professor
Fujian Medical University Union Hospital,China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
September 21, 2016
First Posted
October 12, 2016
Study Start
September 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share