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
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
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
NCT ID
NCT04512469
First Posted
July 7, 2020
Last Updated
August 12, 2020
Sponsor
Lawson Health Research Institute
Collaborators
Ethicon, Inc.
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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