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

Stomach Neoplasms Clinical Trial

Official title:

The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes for Laparoscopic Gastrectomy— A Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03482609
• Other study ID #: FujianMU
• Status: Active, not recruiting
• Start date: July 1, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2020
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Referred
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative referred pain in the left shoulder within 1 month	The incidence of postoperative referred pain in the left shoulder within 1 month	30 days
Secondary	overall postoperative morbidity rates	overall postoperative morbidity rates	30 days
Secondary	3-year disease overall survival rate	3-year disease overall survival rate	36 months
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	3-year recurrence pattern	3-year recurrence pattern	36 months
Secondary	intraoperative morbidity rates	The intraoperative morbidity rates are defined as the rates of event observed within operation.	1 day
Secondary	overall postoperative serious morbidity rates	overall postoperative serious morbidity rates	30 days
Secondary	postoperative recovery course	postoperative recovery course	30 days
Secondary	postoperative nutritional status and quality of life	postoperative nutritional status and quality of life	30 days
Secondary	inflammatory and immune response	inflammatory and immune response	7 days