Stomach Neoplasms
Conditions
Brief summary
The purpose of this study is to explore the effect of postoperative referred pain in the left shoulder on short-term outcomes for laparoscopic gastrectomy
Detailed description
A prospective cohort study will be performed to explore the effect of postoperative referred pain in the left shoulder on short-term outcomes for laparoscopic（including robot assisted laparoscopic surgery） gastrectomy .The evaluation parameters are overall postoperative morbidity rates,perioperative clinical efficacy 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
No
Inclusion criteria
* Age from 18 to 75 years * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * cT1-4a, 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
* patients whose previous history of chronic shoulder pain * 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 * Difficulty of understanding V A S(Visual Analogues Score).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative referred pain in the left shoulder within 1 month | 30 days | The incidence of postoperative referred pain in the left shoulder within 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease overall survival rate | 36 months | 3-year disease overall survival rate |
| 3-year disease free survival rate | 36 months | 3-year disease free survival rate |
| 3-year recurrence pattern | 36 months | 3-year recurrence pattern |
| intraoperative morbidity rates | 1 day | The intraoperative morbidity rates are defined as the rates of event observed within operation. |
| overall postoperative morbidity rates | 30 days | overall postoperative morbidity rates |
| postoperative recovery course | 30 days | postoperative recovery course |
| postoperative nutritional status and quality of life | 30 days | postoperative nutritional status and quality of life |
| inflammatory and immune response | 7 days | inflammatory and immune response |
| overall postoperative serious morbidity rates | 30 days | overall postoperative serious morbidity rates |
Countries
China
Outcome results
None listed