Stomach Neoplasms
Conditions
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.
Interventions
None listed
Sponsors
Fujian Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rate | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 3-year recurrence pattern | 36 months | — |
| Time to first ambulation | 10 days | The data of postoperative recovery course. |
| The number of lymph node dissection | 1 day | — |
| 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 flatus | 10 days | — |
| Time to first liquid diet | 10 days | — |
| Time to soft diet | 10 days | — |
| Duration of hospital stay | 10 days | — |
| Intraoperative lymph node dissection time | 1 days | intraoperative lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph |
| The amount of abdominal drainage | 10 days | — |
| Blood transfusion | 10 days | — |
| 3-year disease overall survival rate | 36 months | — |
| Intraoperative morbidity rates | 1 day | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. |
| The rate of conversion to laparotomy | 1 day | — |
| The variation of cholesterol | 12 months | The variation of cholesterol on postoperative 3, 6, 9 and 12 months |
| The variation of albumin | 12 months | The variation of albumin on postoperative 3, 6, 9 and 12 months |
| The results of endoscopy | 12 months | the results of endoscopy on postoperative 3 and 12 months |
| 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 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 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. |
| 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. |
| 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. |
| 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. |
| The number of positive lymph nodes | 1 day | — |
Countries
China
Outcome results
None listed