Status:
NOT_YET_RECRUITING
Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Incisional Hernia of Anterior Abdominal Wall
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study Design: Single-blinded, randomized, prospective clinical trial. Study Population: End-stage liver disease patients' candidates for liver transplantation. Study procedures: Consenting patients w...
Detailed Description
An incisional hernia is a common complication of abdominal surgery with an incidence of 4-20%. Liver transplant patients represent a unique cohort of surgical patients with immediate immune suppressio...
Eligibility Criteria
Inclusion
- • All patients above 18 years of age undergoing liver transplantation
Exclusion
- Non consenting patients
- patients with skin or deep tissue infections at the time of surgery
- prior mesh infection from hernia repair will be excluded
- entry into the gastro-intestinal system (i.e., need for hepaticojejunostomy for transplantation versus just a standard biliary-biliary anastomosis)
- prior biliary stent (causes colonization of the biliary track and increases surgical site infection)
- patients that are unstable, requiring pressors, or required \>4 units of packed red blood cell transfusions intra-operatively will be excluded as to not prolong surgical time.
- Pregnant women
- Prior incisional hernia/history of IH and repair
- Death within 1-year
- Insufficient follow up
- Connective tissue disorders
- Prior significant wound dehiscence or infection
- Spontaneous bacterial peritonitis
- Primary sclerosing cholangitis (requires roux en y reconstruction thereby entry into the Alimentary track)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04512469
Start Date
September 1 2020
End Date
September 1 2026
Last Update
August 13 2020
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