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

• Conditions: Anastomotic Leakage
• Interventions: Device: LifeSeal® Kit

• Registration Number: NCT02881359
• Lead Sponsor: LifeBond Ltd.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-29
• Study Start: 2016-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-04-02
• Primary Completion: 2018-08
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LifeSeal® Kit	LifeSeal® Kit	creation of a coloanal or colorectal anastomosis

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative clinical anastomotic leaks at discharge	discharge from hospital 3-14 days post surgery

Secondary Outcome Measures

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

Trial Locations

Locations (8)

AZ Delta; 🇧🇪 Roeselare, Belgium

ZGT; 🇳🇱 Almelo, Netherlands

ZNA Antwerpen Campus; 🇧🇪 Antwerpen, Belgium

Jan Yperman Ziekenhuis; 🇧🇪 Ieper, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

CHR de la Citadelle; 🇧🇪 Liege, Belgium

Algemeen Stedelijk Ziekenhuis; 🇧🇪 Aalst, Belgium

H. Hartziekenhuis; 🇧🇪 Mol, Belgium