Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer: Multicenter Prospective Randomized Comparison Study
We investigate the effect on drainage amount of Bio-absorbable Felt(NEOVEIL®) after D1+b or
D2 lymphadenectomy with distal gastrectomy for early gastric cancer.
This study is an randomised controlled trial undertaken in 7 centers in South Korea.
Patients with stage I-II gastric cancer who is going to have curative distal gastrectomy
with D1+b or D2 lymphadenectomy are randomly assigned to use bio-absorbable felt(NEOVEIL®)
or not to use it. Block randomisation will be done by a central interactive computerised
system, stratified by center.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Time to drain removal
Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding.
WOO JIN HYUNG, M.D. Ph.D.
Yonsei University Health System
South Korea: Korea Food and Drug Administration (KFDA)