ABSTRACT
Background: Approximately 10 000 patients undergo cystectomy/ileal conduit annually in the USA, of whom over 70% subsequently develop a parastomal hernia (PSH). Still, no well-established "best" practice for stoma creation to prevent a PSH exists. Objective: To measure the relationship between incision size/type/material and axial tension force (ATF) as a surrogate for herniation force, using several models to mimic abdominal fascia. Design setting and participants: Abdominal fascia models included silicone membrane, ex vivo porcine, and embalmed human cadaveric fascia. A dynamometer pulled a Foley catheter (20 mm/min) with the balloon inflated to 125% incision (linear, cruciate, and circular) diameter using a motorized positioning system. The maximum ATF before herniation was recorded. The study was repeated in unused silicone/tissue for suture reinforcement. We evaluated silicone, ex vivo porcine, and human abdominal fascia. Intervention: Incision sizes (1-3 cm) in 0.5-cm increments were evaluated in silicone. A 3-cm incision was used in porcine/human tissue. Outcome measurements and statistical analysis: ATF for herniation was recorded/compared across incision types/sizes using Mann-Whitney U and Kruskal-Wallis tests as appropriate, with α = 0.05. Results and limitations: Linear incision ATF was significantly greater than cruciate and circular incisions. A cruciate incision had significantly greater ATF than a circular incision. In cadaveric tissue, incisions were significantly greater for linear (34.5 ± 12.8 N) versus cruciate (15.3 ± 2.9 N, p = 0.004) and for cruciate versus circular (p = 0.023) incisions. Results were similar in ex vivo porcine fascia and silicone. Reinforcement with a suture significantly increased ATF in all materials/incision sizes/types. The ex vivo nature is this study's main limitation. Conclusions: This study suggests that urostomy fascial incision type may influence ATF required for herniation. Linear incisions may be preferable. Urostomy reinforcement may significantly increase ATF required for a PSH. These data may help establish best practices for PSH risk reduction. Patient summary: The results of this study illustrate that urostomy fascia incision type may influence the force required to create a parastomal hernia. Linear incisions may be preferable.
ABSTRACT
Tissue-mimicking gels provide a cost-effective medium to optimize histotripsy treatment parameters with immediate feedback. Agarose and polyacrylamide gels are often used to evaluate treatment outcomes as they mimic the acoustic properties and stiffness of a variety of soft tissues, but they do not exhibit high toughness, a characteristic of fibrous connective tissue. To mimic pathologic fibrous tissue found in benign prostate hyperplasia (BPH) and other diseases that are potentially treatable with histotripsy, an optically transparent hydrogel with high toughness was developed that is a hybrid of polyacrylamide and alginate. The stiffness was established using shear wave elastography (SWE) and indentometry techniques and was found to be representative of human BPH ex vivo prostate tissue. Different phantom compositions and excised ex vivo BPH tissue samples were treated with a 700-kHz histotripsy transducer at different pulse repetition frequencies. Post-treatment, the hybrid gels and the tissue samples exhibited differential reduction in stiffness as measured by SWE. On B-mode ultrasound, partially treated areas were present as hyperechoic zones and fully liquified areas as hypoechoic zones. Phase contrast microscopy of the gel samples revealed liquefaction in regions consistent with the target lesion dimensions and correlated to findings identified in tissue samples via histology. The dose required to achieve liquefaction in the hybrid gel was similar to what has been observed in ex vivo tissue and greater than that of agarose of comparable or higher Young's modulus by a factor >10. These results indicate that the developed hydrogels closely mimic elasticities found in BPH prostate ex vivo tissue and have a similar response to histotripsy treatment, thus making them a useful cost-effective alternative for developing and evaluating different treatment protocols.
