Clinical trial NCT03482609: The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes for Laparoscopic Gastrectomy
Official title: The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes 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: 2018-03-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergoing laparoscopic (including robot assisted laparoscopic surgery) radical gastrectomy for gastric cancer are included.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The incidence of postoperative referred pain in the left shoulder within 1 month
timeFrame: 30 days
Secondary outcomes:
measure: overall postoperative morbidity rates
timeFrame: 30 days
measure: 3-year disease overall survival rate
timeFrame: 36 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: intraoperative morbidity rates
timeFrame: 1 day
measure: overall postoperative serious morbidity rates
timeFrame: 30 days
measure: postoperative recovery course
timeFrame: 30 days
measure: postoperative nutritional status and quality of life
timeFrame: 30 days
measure: inflammatory and immune response
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: