An interventional study of Low molecular weight mesh in Incisional Hernia of Anterior Abdominal Wall, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Prevention
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:
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.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Device: Low molecular weight mesh
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.
Rate of incisional hernia post-operatively
The primary outcome will be incisional hernia rate at 1 year post-operatively.
Time frame: 1 year
Rate of incisional hernia post-operatively
Incisional hernia rates at post-operative year 2
Time frame: 2 years
Rate of surgical complications
Assess rate of surgical complications as per Clavien Dindo classification
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's →