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Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients

Primary Purpose

Incisional Hernia of Anterior Abdominal Wall

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low molecular weight mesh
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia of Anterior Abdominal Wall focused on measuring liver transplant, incisional hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• All patients above 18 years of age undergoing liver transplantation

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Treatment Group - Mesh

    Arm Description

    The control group will undergo standard running fascial closure with PDS .

    The treatment group will undergo standard running fascial closure with PDS plus a low molecular weight mesh extending 3 cm from the fascial incision.

    Outcomes

    Primary Outcome Measures

    Rate of incisional hernia post-operatively
    The primary outcome will be incisional hernia rate at 1 year post-operatively.

    Secondary Outcome Measures

    Rate of incisional hernia post-operatively
    Incisional hernia rates at post-operative year 2
    Rate of surgical complications
    Assess rate of surgical complications as per Clavien Dindo classification

    Full Information

    First Posted
    July 7, 2020
    Last Updated
    August 12, 2020
    Sponsor
    Lawson Health Research Institute
    Collaborators
    Ethicon, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04512469
    Brief Title
    Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients
    Official Title
    A Randomized Controlled Trial Examining the Efficacy of Prophylactic on Lay Mesh Versus Standardized Fascial Closure on Ventral Incisional Hernia Rates in Liver Transplant Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lawson Health Research Institute
    Collaborators
    Ethicon, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    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 will be divided into two matched groups: CONTROL group - receiving a standard running fascial closure with PDS suture TREATMENT group - receiving a standard running fascial closure with PDS suture PLUS a low molecular weight mesh. The mesh will be secured to the fascia extending 3 cm from the incisional site. There will be no modifications to routine post-operative wound care in both groups. However, the treatment group will have an additional drain placed at the incision site compared to the control group to reduce the risk of a seroma from placement of the mesh. Wound dressing will be removed on post-op day 2 and the wound will be assessed. Re-application of the dressing will occur thereafter until proper healing of the incision. An abdominal ultrasound will be done on all study participants at the 1- and 2-year mark postoperatively to look for objective evidence of a ventral incisional hernia. A CT scan will be performed if the abdominal ultrasound findings are inconclusive.
    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 suppression post-operatively. It is presumed that this immune suppression accompanied by significant co-morbidities have led to high incisional ventral hernia rates between 4.9%-34.3%. A recent 2018 retrospective review of 1044 liver transplant patients identified age >55, high BMI > 25, and immediate rejection were significant risk factors contributing to herniation. However, previously concerning considerations including gender, diagnosis, diabetes, Child-Pugh score, MELD score, donor type, hepato-renal syndrome, varix bleeding, ascites, hepatic encephalopathy, ventilator use, spontaneous bacterial peritonitis (SBP), or bile leak were not identified as significant risk factors. Moreover, the mortality for chronic liver disease patients for elective hernia repair is 3.7% at 90 days and morbidity is 27%. Emergent hernia repair led to 10% 90-day mortality with 60% morbidity. The high incidence of herniation represents a common problem with significant morbidity and mortality post liver transplantation thereby requiring investigating a new preventative solution. A recent retrospective trial in the colorectal literature identified an institutional incidence of incisional hernia for colorectal patients of 39.9%. They recognized two high-risk populations, obese, and non-obese with a combination of several secondary risk factors. A follow-up prospective cohort study separated all colorectal patients undergoing laparotomy to standardized running PDS closure versus those with BMI>29 (the median in the prior study) and those BMI <29 with >=2 risk factors to include standard closure with an on-lay Ultrapro partially absorb-able mesh covering 3 cm adjacent to the incision placed with double down facial staples followed by a subcutaneous drain. The reported risk factors included BMI, smoking, serum creatinine, hemoglobin, serum albumin, COPD diabetes, immune suppression with steroids or radiation/chemotherapy, and previous midline laparotomy. The results revealed a decrease in the incisional hernia rate from 43.9% to 10% (P=0.0001). This study also concluded the treatment was cost effective and safe.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incisional Hernia of Anterior Abdominal Wall
    Keywords
    liver transplant, incisional hernia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The research coordinators will identify patients diagnosed with end-stage liver disease who are candidates for liver transplantation for study eligibility (see inclusion and exclusion criteria). Participants will be randomly selected to be included in one of two groups: the control or treatment group. The control group will undergo standard running fascial closure with PDS while the treatment group will undergo this closure plus a low molecular weight mesh extending 3 cm from the fascial incision. There will be no alteration to this standard of care schedule for this clinical trial. Data will be collected at every 12-month intervals to rule out clinical evidence of a hernia. The presence of a hernia will be assessed via clinical examination and abdominal ultrasound imaging. If findings from the abdominal ultrasound are inconclusive, a non-contrast CT scan will be performed. The study will end when either the primary or secondary outcomes are reached.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The control group will undergo standard running fascial closure with PDS .
    Arm Title
    Treatment Group - Mesh
    Arm Type
    Experimental
    Arm Description
    The treatment group will undergo standard running fascial closure with PDS plus a low molecular weight mesh extending 3 cm from the fascial incision.
    Intervention Type
    Device
    Intervention Name(s)
    Low molecular weight mesh
    Intervention Description
    Following liver implantation, the subcostal incision will be closed using a running fascial closure with absorbable 1-0 Polydioxanone (PDS) suture and staples, with the treatment group also receiving a mesh.
    Primary Outcome Measure Information:
    Title
    Rate of incisional hernia post-operatively
    Description
    The primary outcome will be incisional hernia rate at 1 year post-operatively.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Rate of incisional hernia post-operatively
    Description
    Incisional hernia rates at post-operative year 2
    Time Frame
    2 years
    Title
    Rate of surgical complications
    Description
    Assess rate of surgical complications as per Clavien Dindo classification
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • All patients above 18 years of age undergoing liver transplantation Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    George Jada, MD
    Phone
    416-388-9421
    Email
    george.jada@lhsc.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anton Skaro, MD
    Phone
    519-663-2904
    Email
    Anton.Skaro@lhsc.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anton Skaro, MD
    Organizational Affiliation
    Associate Professor - Surgery, Schulich School of Medicine & Dentistry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29503821
    Citation
    Argudo N, Pera M, Lopez-Cano M, Hernandez L, Sancho JJ, Grande L, Pereira JA. Selective Mesh Augmentation to Prevent Incisional Hernias in Open Colorectal Surgery Is Safe and Cost-Effective. Front Surg. 2018 Feb 16;5:8. doi: 10.3389/fsurg.2018.00008. eCollection 2018. No abstract available.
    Results Reference
    result
    PubMed Identifier
    22683615
    Citation
    Bachir NM, Larson AM. Adult liver transplantation in the United States. Am J Med Sci. 2012 Jun;343(6):462-9. doi: 10.1097/MAJ.0b013e3182308b66.
    Results Reference
    result
    PubMed Identifier
    6279229
    Citation
    Bucknall TE, Cox PJ, Ellis H. Burst abdomen and incisional hernia: a prospective study of 1129 major laparotomies. Br Med J (Clin Res Ed). 1982 Mar 27;284(6320):931-3. doi: 10.1136/bmj.284.6320.931.
    Results Reference
    result
    PubMed Identifier
    8639725
    Citation
    Israelsson LA, Jonsson T. Incisional hernia after midline laparotomy: a prospective study. Eur J Surg. 1996 Feb;162(2):125-9.
    Results Reference
    result
    PubMed Identifier
    3155634
    Citation
    Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg. 1985 Jan;72(1):70-1. doi: 10.1002/bjs.1800720127.
    Results Reference
    result
    PubMed Identifier
    22769029
    Citation
    Pereira JA, Pera M, Grande L. [Incidence of incisional hernia after open and laparoscopic colorectal cancer resection]. Cir Esp. 2013 Jan;91(1):44-9. doi: 10.1016/j.ciresp.2012.05.004. Epub 2012 Jul 4. Spanish.
    Results Reference
    result
    PubMed Identifier
    15686704
    Citation
    Piazzese E, Montalti R, Beltempo P, Bertelli R, Puviani L, Pacile V, Nardo B, Cavallari A. Incidence, predisposing factors, and results of surgical treatment of incisional hernia after orthotopic liver transplantation. Transplant Proc. 2004 Dec;36(10):3097-8. doi: 10.1016/j.transproceed.2004.10.047.
    Results Reference
    result
    PubMed Identifier
    17000384
    Citation
    Vardanian AJ, Farmer DG, Ghobrial RM, Busuttil RW, Hiatt JR. Incisional hernia after liver transplantation. J Am Coll Surg. 2006 Oct;203(4):421-5. doi: 10.1016/j.jamcollsurg.2006.06.017. Epub 2006 Aug 17.
    Results Reference
    result

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    Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients

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