Incisional Hernia of Anterior Abdominal Wall Clinical Trial
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 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:
1. CONTROL group - receiving a standard running fascial closure with PDS suture
2. 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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06251583 -
Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site.
|
Phase 3 |