Clinical trial NCT02930291: The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy
Official title: The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy- A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergoing laparoscopic radical gastrectomy for gastric cancer are included.

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.

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
* 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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
Secondary outcomes:
measure: 3-year disease overall survival rate
timeFrame: 36 months
measure: Morbidity and mortality
timeFrame: 30 days; 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Time to first ambulation
timeFrame: 10 days
measure: The number of lymph node dissection
timeFrame: 1 day
measure: The variation of weight
timeFrame: 12 months
measure: The daily highest body temperature
timeFrame: 7 day
measure: Time to first flatus
timeFrame: 10 days
measure: Time to first liquid diet
timeFrame: 10 days
measure: Time to soft diet
timeFrame: 10 days
measure: Duration of hospital stay
timeFrame: 10 days
measure: Intraoperative lymph node dissection time
timeFrame: 1 days
measure: The amount of abdominal drainage
timeFrame: 10 days
measure: Blood transfusion
timeFrame: 10 days
measure: The number of positive lymph nodes
timeFrame: 1 day
measure: Intraoperative morbidity rates
timeFrame: 1 day
measure: The rate of conversion to laparotomy
timeFrame: 1 day
measure: The variation of cholesterol
timeFrame: 12 months
measure: The variation of albumin
timeFrame: 12 months
measure: The results of endoscopy
timeFrame: 12 months
measure: The values of white blood cell count
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The values of lymphocyte count
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The values of neutrophil differential count
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The values of platelet count
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The values of hemoglobin
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The values of C-reactive protein
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The values of prealbumin
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: Visual Analog Score for pain
timeFrame: 7 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital,China
name: Changming Huang, Professor
role: PRINCIPAL_INVESTIGATOR
References: