SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit

LifeBond Ltd.200 enrolled

Overview

This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate

The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Anastomotic Leakage

Interventions

LifeSeal® KitDEVICE

used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 years of age at screening visit 2. Written informed consent obtained 3. Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis\* created within 15 cm from the anal verge. 4. Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU Exclusion Criteria: 1\. Subject with American Society of Anesthesiology (ASA) status \> 3.

Locations (8)

Algemeen Stedelijk Ziekenhuis

Aalst, Belgium

ZNA Antwerpen Campus

Antwerp, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Jan Yperman Ziekenhuis

Ieper, Belgium

Outcomes

Primary Outcomes

Incidence of post-operative clinical anastomotic leaks at discharge

Time frame: discharge from hospital 3-14 days post surgery

Secondary Outcomes

Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery

Time frame: up to 4 weeks post surgery

Data from ClinicalTrials.gov

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