The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes for Laparoscopic Gastrectomy

• Conditions: Stomach Neoplasms

• Registration Number: NCT03482609
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-29
• Study Start: 2018-07-01
• Primary Completion: 2018-11-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
3-year disease overall survival rate	36 months	3-year disease overall survival rate
overall postoperative serious morbidity rates	30 days	overall postoperative serious 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 morbidity rates	30 days	overall postoperative morbidity rates
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.

Trial Locations

Locations (1)

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