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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02930291
• Other study ID #: 2016YF017-02
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: October 2020

Study information

• Verified date: February 2020
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to explore the effect of preoperative inflammation-based scores on postoperative morbidity and mortality for laparoscopic gastrectomy.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: October 2020
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate		36 months
Secondary	3-year disease overall survival rate		36 months
Secondary	Morbidity and mortality	The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.	30 days; 36 months
Secondary	3-year recurrence pattern		36 months
Secondary	Time to first ambulation	The data of postoperative recovery course.	10 days
Secondary	The number of lymph node dissection		1 day
Secondary	The variation of weight	The variation of weight on postoperative 3, 6, 9 and 12 months	12 months
Secondary	The daily highest body temperature	The daily highest body temperature before discharge	7 day
Secondary	Time to first flatus		10 days
Secondary	Time to first liquid diet		10 days
Secondary	Time to soft diet		10 days
Secondary	Duration of hospital stay		10 days
Secondary	Intraoperative lymph node dissection time	intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph	1 days
Secondary	The amount of abdominal drainage		10 days
Secondary	Blood transfusion		10 days
Secondary	The number of positive lymph nodes		1 day
Secondary	Intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
Secondary	The rate of conversion to laparotomy		1 day
Secondary	The variation of cholesterol	The variation of cholesterol on postoperative 3, 6, 9 and 12 months	12 months
Secondary	The variation of albumin	The variation of albumin on postoperative 3, 6, 9 and 12 months	12 months
Secondary	The results of endoscopy	the results of endoscopy on postoperative 3 and 12 months	12 months
Secondary	The values of white blood cell count	The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The values of lymphocyte count	The values of lymphocyte count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The values of neutrophil differential count	The values of neutrophil differential count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The values of platelet count	The values of platelet count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The values of hemoglobin	The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The values of C-reactive protein	The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	The values of prealbumin	The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.	Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary	Visual Analog Score for pain	the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.	7 days