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

• Conditions: Stomach Neoplasms

• Registration Number: NCT02930291
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-10-08
• Study First Posted: 2016-10-12
• Primary Completion: 2017-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year disease free survival rate	36 months

Secondary Outcome Measures

Name	Time	Method
The variation of cholesterol	12 months	The variation of cholesterol on postoperative 3, 6, 9 and 12 months
3-year recurrence pattern	36 months
The amount of abdominal drainage	10 days
The variation of albumin	12 months	The variation of albumin on postoperative 3, 6, 9 and 12 months
Morbidity and mortality	30 days; 36 months	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.
The variation of weight	12 months	The variation of weight on postoperative 3, 6, 9 and 12 months
The daily highest body temperature	7 day	The daily highest body temperature before discharge
Time to first liquid diet	10 days
Duration of hospital stay	10 days
Time to soft diet	10 days
The values of C-reactive protein	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
The values of prealbumin	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
3-year disease overall survival rate	36 months
Time to first ambulation	10 days	The data of postoperative recovery course.
Intraoperative lymph node dissection time	1 days	intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph
The values of white blood cell count	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
The values of platelet count	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
Visual Analog Score for pain	7 days	the values of visual analog score for pain before operation and on postoperative day 1 to day 7 are recorded.
Blood transfusion	10 days
The number of lymph node dissection	1 day
Time to first flatus	10 days
The number of positive lymph nodes	1 day
Intraoperative morbidity rates	1 day	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
The values of lymphocyte count	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
The values of neutrophil differential count	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
The rate of conversion to laparotomy	1 day
The results of endoscopy	12 months	the results of endoscopy on postoperative 3 and 12 months
The values of hemoglobin	Preoperative 3 days and postoperative 1, 3, and 5 days	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.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China