Rectal Cancer Clinical Trial
Official title:
Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
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.
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