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

• ClinicalTrials.gov Identifier: NCT03482609
• Recruitment Status: Unknown
• First Posted: March 29, 2018
• Last Update Posted: February 12, 2020
• Sponsor: Fujian Medical University
• Information provided by (Responsible Party): Chang-Ming Huang, Prof., Fujian Medical University

Study Description

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

Condition or disease
Stomach Neoplasms

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Months
• Official Title: The Effect of Postoperative Referred Pain in the Left Shoulder on Short-term Outcomes for Laparoscopic Gastrectomy- A Prospective Cohort Study
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: November 1, 2018
• Estimated Study Completion Date: November 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. The incidence of postoperative referred pain in the left shoulder within 1 month [ Time Frame: 30 days ]
   The incidence of postoperative referred pain in the left shoulder within 1 month

Secondary Outcome Measures :

1. overall postoperative morbidity rates [ Time Frame: 30 days ]
   overall postoperative morbidity rates
2. 3-year disease overall survival rate [ Time Frame: 36 months ]
   3-year disease overall survival rate
3. 3-year disease free survival rate [ Time Frame: 36 months ]
   3-year disease free survival rate
4. 3-year recurrence pattern [ Time Frame: 36 months ]
   3-year recurrence pattern
5. intraoperative morbidity rates [ Time Frame: 1 day ]
   The intraoperative morbidity rates are defined as the rates of event observed within operation.
6. overall postoperative serious morbidity rates [ Time Frame: 30 days ]
   overall postoperative serious morbidity rates
7. postoperative recovery course [ Time Frame: 30 days ]
   postoperative recovery course
8. postoperative nutritional status and quality of life [ Time Frame: 30 days ]
   postoperative nutritional status and quality of life
9. inflammatory and immune response [ Time Frame: 7 days ]
   inflammatory and immune response

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergoing laparoscopic (including robot assisted laparoscopic surgery) radical gastrectomy for gastric cancer are included.

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).

Contacts and Locations

Locations

China, Fujian

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Sponsors and Collaborators

Fujian Medical University

Investigators

• Principal Investigator: Changming Huang, professor; Fujian Medical University Union Hospital,China

More Information

Additional Information:

• Responsible Party: Chang-Ming Huang, Prof., Professor, Fujian Medical University
• ClinicalTrials.gov Identifier: NCT03482609
• Other Study ID Numbers: FujianMU
• First Posted: March 29, 2018
• Last Update Posted: February 12, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Stomach Neoplasms; Pain, Referred; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pain; Neurologic Manifestations