Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery|
- Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. [ Time Frame: Discharge and 1 Month post surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
PSD Veritas Collagen Matrix Reinforcement Arm
Device: Staple line reinforcement
Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.
Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|United States, Minnesota|
|Colon & Rectal Surgery Associates|
|St. Paul, Minnesota, United States, 55105|
|Principal Investigator:||Richard Karulf, MD||Colon & Rectal Surgery Associates|