The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy- A Prospective Cohort Study

Fujian Medical University1 site in 1 country310 target enrollmentSeptember 2016

ConditionsStomach Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stomach Neoplasms
Sponsor: Fujian Medical University
Enrollment: 310
Locations: 1
Primary Endpoint: 3-year disease free survival rate
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

A prospective cohort study will be performed to explore the effect of preoperative inflammation-based scores on postoperative morbidity and mortality for laparoscopic gastrectomy.The evaluation parameters are perioperative clinical efficacy, postoperative complications and 3-year survival and recurrence rates.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

October 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Fujian Medical University

Responsible Party

Principal Investigator

Chang-Ming Huang, Prof.

Director, Principal Investigator, Clinical Professor

Fujian Medical University

Eligibility Criteria

Inclusion Criteria

•Age from 18 to 75 years
•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

Exclusion Criteria

•Women during pregnancy or breast-feeding
•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

Outcomes

Primary Outcomes

3-year disease free survival rate

Time Frame: 36 months

Secondary Outcomes

The amount of abdominal drainage(10 days)
The variation of albumin(12 months)
3-year recurrence pattern(36 months)
Morbidity and mortality(30 days; 36 months)
The variation of weight(12 months)
The daily highest body temperature(7 day)
Time to first liquid diet(10 days)
Duration of hospital stay(10 days)
Time to soft diet(10 days)
The variation of cholesterol(12 months)
The values of C-reactive protein(Preoperative 3 days and postoperative 1, 3, and 5 days)
The values of prealbumin(Preoperative 3 days and postoperative 1, 3, and 5 days)
3-year disease overall survival rate(36 months)
Time to first ambulation(10 days)
Intraoperative lymph node dissection time(1 days)
The values of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
The values of platelet count(Preoperative 3 days and postoperative 1, 3, and 5 days)
Visual Analog Score for pain(7 days)
The number of lymph node dissection(1 day)
Time to first flatus(10 days)
Blood transfusion(10 days)
The number of positive lymph nodes(1 day)
Intraoperative morbidity rates(1 day)
The values of lymphocyte count(Preoperative 3 days and postoperative 1, 3, and 5 days)
The values of neutrophil differential count(Preoperative 3 days and postoperative 1, 3, and 5 days)
The rate of conversion to laparotomy(1 day)
The results of endoscopy(12 months)
The values of hemoglobin(Preoperative 3 days and postoperative 1, 3, and 5 days)