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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Anastomotic Leakage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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LifeSeal® Kit

creation of a coloanal or colorectal anastomosis

LifeSeal® Kit

Intervention Type DEVICE

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.

Interventions

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LifeSeal® Kit

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.

Intervention Type DEVICE

Eligibility Criteria

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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