LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored. RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis. In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge. STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery. SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
736
LifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis
University of Southern CA
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Florida Hospital
Florida City, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Chicago
Incidence of overall anastomotic leak
Time frame: Up to 17 weeks post surgery
Incidence of post operative anastomotic leaks
Time frame: Up to 17 weeks post surgery
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Chicago, Illinois, United States
Franciscan
Indianapolis, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
Jefferson, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
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