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
1 other identifier
observational
200
2 countries
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedApril 2, 2018
March 1, 2018
1.8 years
August 23, 2016
March 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of post-operative clinical anastomotic leaks at discharge
discharge from hospital 3-14 days post surgery
Secondary Outcomes (1)
Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery
up to 4 weeks post surgery
Study Arms (1)
LifeSeal® Kit
creation of a coloanal or colorectal anastomosis
Interventions
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 Criteria
All patients who are treated with LifeSeal® and comply with the eligibility criteria will be offered to participate in the study.
You may qualify if:
- ≥ 18 years of age at screening visit
- Written informed consent obtained
- 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.
- Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU
You may not qualify if:
- \. Subject with American Society of Anesthesiology (ASA) status \> 3.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeBond Ltd.lead
Study Sites (8)
Algemeen Stedelijk Ziekenhuis
Aalst, 9300, Belgium
ZNA Antwerpen Campus
Antwerp, 2060, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Jan Yperman Ziekenhuis
Ieper, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
H. Hartziekenhuis
Mol, 2400, Belgium
AZ Delta
Roeselare, Belgium
ZGT
Almelo, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 4 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2016
First Posted
August 29, 2016
Study Start
October 1, 2016
Primary Completion
August 1, 2018
Study Completion
September 1, 2018
Last Updated
April 2, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share