Effect of a Reinforced Staple Line on Leak Rate in Distal Pancreatectomy
Pancreatic leak remains a significant cause of morbidity and extra cost following distal
pancreatectomy. Historically, previous attempts to reduce the leak rate have met with
limited success. To examine this problem the investigators propose a randomized, controlled
trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic
transection. For the duration of the study period, participating surgeons will utilize a
standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh
(SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to
reinforce the stapled pancreatic transection line in the test group. In order to have a
uniform test method, the investigators will utilize a laparoscopic stapling device for both
open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed
in the left upper quadrant at the time of resection. Drainage of the pancreatic resection
bed is widely accepted and remains our current standard of care.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
To determine if mesh reinforced pancreatic transaction (via SEAMGUARD® or PERI-STRIPS DRY®) decreases the incidence of pancreatic leak following distal pancreatectomy.
Reinforcing the stapled pancreatic transection line with a reabsorbable polytrimethylene carbonate mesh will significantly decrease the amount of amylase rich fluid present in the drain "pancreatic leak" and the duration (number of days) amylase rich fluid is present in the drain. To compare the two types of mesh (SEAMGUARD® or PERI-STRIPS DRY®)to determine the the incidence of pancreatic leak following distal pancreatectomy.
William Hawkins, M.D.
Washington University School of Medicine
United States: Institutional Review Board
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