Spots Global Cancer Trial Database for Dumping Syndrome and Quality of Life After Vagus Nerve-preserving Distal Gastrectomy
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Trial Identification
Brief Title: Dumping Syndrome and Quality of Life After Vagus Nerve-preserving Distal Gastrectomy
Official Title: Incidence of Dumping Syndrome After Laparoscopic Vagus Nerve-preserving Distal Gastrectomy for Early Gastric Cancer
Study ID: NCT03880747
Conditions
Interventions
Study Description
Brief Summary: There is no consensus on what type of function-preserving gastrectomy can provide the best patient quality of life (QOL). This study aims to evaluate the incidence of dumping syndrome after vagus nerve-preserving distal gastrectomy (VPNDG).
Detailed Description: The study is designed as a prospective observational phase II study with a follow-up period of 12 months. Patients diagnosed with early gastric cancer in the distal 2/3rd of the stomach who are planned to undergo laparoscopic VPNDG with Roux-en Y gastrojejunostomy will be enrolled. Primary endpoint is incidence of dumping syndrome defined by Sigstad score 7 after a 3-month interval. Other outcomes include operative data, early complication, and patient QOL using the European Organization for Research and Treatment of Cancer C-30 and STO22 modules.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea, Republic of
Contact Details
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