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

SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection

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

Study Overview

• Status: Unknown
• Conditions: Anastomotic Leakage
• Intervention / Treatment: Device: LifeSeal® Kit

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Algemeen Stedelijk Ziekenhuis
  • Antwerpen, Belgium, 2060
    • ZNA Antwerpen Campus
  • Hasselt, Belgium
    • Jessa Ziekenhuis
  • Ieper, Belgium
    • Jan Yperman ziekenhuis
  • Liege, Belgium, 4000
    • CHR de la Citadelle
  • Mol, Belgium, 2400
    • H. Hartziekenhuis
  • Roeselare, Belgium
    • AZ Delta
• Netherlands
  • Almelo, Netherlands
    • ZGT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who are treated with LifeSeal® and comply with the eligibility criteria will be offered to participate in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LifeSeal® Kit; creation of a coloanal or colorectal anastomosis	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of post-operative clinical anastomotic leaks at discharge	discharge from hospital 3-14 days post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery	up to 4 weeks post surgery

Collaborators and Investigators

• Sponsor: LifeBond Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 29, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: CLP-LS-0146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO