Inter- and Intra-Observer Variability and the Effect of Experience in Cine-MRI for Adhesion Detection.

Cine-MRI for adhesion detection is a promising novel modality that can help the large group of patients developing pain after abdominal surgery. Few studies into its diagnostic accuracy are available, and none address observer variability. This retrospective study explores the inter- and intra-observer variability, diagnostic accuracy, and the effect of experience. A total of 15 observers with a variety of experience reviewed 61 sagittal cine-MRI slices, placing box annotations with a confidence score at locations suspect for adhesions. Five observers reviewed the slices again one year later. Inter- and intra-observer variability are quantified using Fleiss' (inter) and Cohen's (intra) κ and percentage agreement. Diagnostic accuracy is quantified with receiver operating characteristic (ROC) analysis based on a consensus standard. Inter-observer Fleiss' κ values range from 0.04 to 0.34, showing poor to fair agreement. High general and cine-MRI experience led to significantly (p < 0.001) better agreement among observers. The intra-observer results show Cohen's κ values between 0.37 and 0.53 for all observers, except one with a low κ of -0.11. Group AUC scores lie between 0.66 and 0.72, with individual observers reaching 0.78. This study confirms that cine-MRI can diagnose adhesions, with respect to a radiologist consensus panel and shows that experience improves reading cine-MRI. Observers without specific experience adapt to this modality quickly after a short online tutorial. Observer agreement is fair at best and area under the receiver operating characteristic curve (AUC) scores leave room for improvement. Consistently interpreting this novel modality needs further research, for instance, by developing reporting guidelines or artificial intelligence-based methods.

Comparability of histological outcomes in rats and humans in a hernia model.

BACKGROUND: Hernia repair is one of the most frequently performed operations. In search of the ideal mesh for hernia repair, animal research is required. Although rats are most often used in experimental mesh experiments, no correlation with clinical findings in humans has ever been shown. Therefore, the aim of our study was to investigate whether adhesion formation and foreign body reactions to meshes in rats are comparable with the reactions in humans. MATERIALS AND METHODS: A fixed type of mesh was implanted intraperitoneally in a group of 10 rats and 10 patients undergoing elective, temporary stoma formation. In case of the latter, meshes were placed around the stoma. After a follow-up period of 12 wk in rats and after a median follow-up of 6 mo in humans, samples of the mesh were collected. Adhesion assessments were performed, and (immuno-) histochemical evaluation was performed by a specialized experimental pathologist and an experienced clinical pathologist. RESULTS: After the follow-up period, adhesion formation did not differ significantly between rats and humans. Moreover, general inflammation scores were comparable, although granulocytes and giant cells were more present in rats, compared with humans. On the other hand, the presence of fibrosis was more evident in humans compared with rats. CONCLUSIONS: To our knowledge, this is the first study, which showed that a specific animal model, namely a rat model, correlates with adhesion formation and the foreign body reaction to meshes in humans. It can be recommended to use rats in future experimental mesh for incisional hernia research.

Impact of tissue adhesives on the prevention of anastomotic leakage of colonic anastomoses: an in vivo study.

BACKGROUND: Tissue adhesives (TA) may be useful to strengthen colorectal anastomoses, thereby preventing anastomotic leakage (AL). Previous studies have identified cyanoacrylate (CA) TAs as the most promising colonic anastomotic sealants. This study investigates the protective effects of sealing colonic anastomoses with various CAs. MATERIALS AND METHODS: Fifty-five Wistar rats underwent laparotomy and transection of the proximal colon. An anastomosis was created with 4 interrupted sutures followed by either application of Histoacryl Flexible, Omnex, Glubran 2, or no TA seal. An additional control group was included with a 12-suture anastomosis and no TA seal. After 7 days, the rats were sacrificed and scored for the presence of AL as the main outcome. Secondary outcomes were the occurrence of bowel obstruction, adhesions, and anastomotic bursting pressure. Histological evaluation was performed. RESULTS: The highest AL rate was found in the Glubran 2 group (7/11), followed by the 4-sutures group without TA (5/11), and the Omnex group (5/11). Histoacryl Flexible showed the lowest AL rate (2/11). In the control group, only one rat showed signs of AL. Histologically, the highest influx of inflammatory cells was found in the 4-suture group without TA and for Omnex and Glubran 2. Histoacryl Flexible caused more mature collagen deposition when compared to the other TA groups. CONCLUSIONS: Histoacryl Flexible showed the lowest leakage rate compared to the other TA groups and to the 4-suture control group. Glubran 2 showed the highest AL rate and a high inflammatory response. Histoacryl Flexible was associated with the presence of more mature collagen and seems to promote anastomotic healing.

Biocompatibility and biomechanical analysis of elastic TPU threads as new suture material.

High suture tension is one of the causes for many wound-healing problems. Constriction of tissue within the suture loops of nonelastic sutures can lead to cutting of the suture through tissues and necrosis of the tissue within these loops. The use of elastic materials in new suture types could give the material the ability to adapt tension to the tissue requirements and subsequently lead to more vital tissue within its loops. We evaluated the foreign body host response, as indicator of biocompatibility, to a new thermoplastic poly(carbonate) urethane (TPU) synthetic suture material in a rat model compared with standard nonelastic polypropylene (PP) sutures. Tissue samples were collected at 7 and 21 days, and host response was evaluated. Subsequently, suture tension curves of the new elastic sutures for the first 30 min after knotting were recorded in a pig model. The new TPU sutures showed an improved foreign body response when compared with that of PP, with a reduction in the amount of macrophages surrounding the material. Tension experiments showed a superior tension curve for TPU sutures, with a major reduction in peak suture tension when compared with that of standard PP sutures, while still retaining adequate tension after 30 min. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 99-106, 2017.

A new poly(1,3-trimethylene carbonate) film provides effective adhesion reduction after major abdominal surgery in a rat model.

BACKGROUND: Postoperative adhesions remain a major clinical problem after abdominal surgery. We evaluated the efficacy of a new poly(trimethylene carbonate) (PTMC) film as an antiadhesive material. In many abdominal operations, there is an increased risk of fecal contamination; the risk of (increased) infection in presence of PTMC film was studied in 2 additional animal models. METHODS: A validated rat adhesion model with peritoneal ischemic buttons was used to compare the new PTMC film with a hyaluronate carboxymethylcellulose (HA-CMC) sheet, icodextrin solution, and a control group. Primary endpoint was occurrence of adhesions at the ischemic buttons after 14 days in 44 rats (n = 11 per group). To evaluate potential risks associated with the film, both an anastomotic leakage model and a cecal ligation and puncture model were used. Kruskal-Wallis tests with subsequent Mann-Whitney tests were used to detect differences between groups. RESULTS: PTMC film showed a significant reduction in the amount of adhesions (median, 0.5 buttons) compared with control group (median, 4 buttons; P < .001) and icodextrin group (median, 4.5; P < .001). The amount of adhesions was similar to the HA-CMC group (median, 2; P = .04). The presence of the film did not increase the risk of anastomotic leakage or bacterial growth in a contaminated environment. CONCLUSION: The presence of a PTMC film leads to a significant reduction in the amount of adhesions after 14 days in an ischemic button rat model. Furthermore, this film was found to be safe in an animal model, even in complex abdominal operations with an increased risk of fecal contamination.

Elastic mesh with thermoplastic polyurethane filaments preserves effective porosity of textile implants.

In hernia surgery, meshes with small pores tend to be filled by fibrous tissue, which reduces their stretchability and causes patient complaints. Because of the inelasticity of current meshes, mechanical strain might cause pores to collapse even in large-pore mesh constructions. In this study, a mesh with elastic thermoplastic polyurethane (TPU) filaments was constructed to prevent pore size changes even under mechanical strain, and its biocompatibility in comparison with polyvinylidene fluoride (PVDF) was evaluated. A mesh was constructed using PVDF with elastic TPU filaments and mechanically tested. After midline laparotomy in 20 rabbits, we placed a 15 cm × 3 cm mesh as inlay in the defect. Animals were randomized to either the TPU or PVDF group. After 7 or 21 days, mesh expansion was measured under pneumoperitoneum, and abdominal walls were explanted for immunohistochemical investigations. In vitro, TPU meshes showed a slight reduction in effective porosity from 46% at tension-free conditions to 26% under longitudinal and to 34% under transverse strain. The nonelastic PVDF meshes showed a marked reduction in effective porosity from 70% to 7% and 52%, respectively. The TPU mesh had a breaking elongation of 101% and a tensile strength of 35 N/cm. In vivo, both meshes achieved healing of the incision without hernial defect. The TPU mesh maintained its elasticity under pneumoperitoneum. The amount of CD68-positive, Ki67-positive, and apoptotic cells was significantly lower in the TPU group after 7 and 21 days. The newly developed TPU mesh shows elasticity, structural stability, and preserved effective porosity under mechanical strain. Immunohistochemistry indicates superior biocompatibility of TPU mesh compared with PVDF after 7 and 21 days.

Utilization of flax fibers for biomedical applications.

Over the past decades, a large number of animal-derived materials have been introduced for several biomedical applications. Surprisingly, the use of plant-based materials has lagged behind. To study the feasibility of plant-derived biomedical materials, we chose flax (Linum usitatissimum). Flax fibers possess excellent physical-mechanical properties, are nonbiodegradable, and there is extensive know-how on weaving/knitting of them. One area where they could be useful is as implantable mesh structures in surgery, in particular for the repair of incisional hernias of the abdominal wall. Starting with a bleached flax thread, a prototype mesh was specifically knitted for this study, and its cytocompatibility was studied in vitro and in vivo. The experimental data revealed that application of flax in surgery first requires a robust method to remove endotoxins and purify the flax fiber. Such a method was developed, and purified meshes did not cause loss of cell viability in vitro. In addition, endotoxins determined using limulus amebocyte lysate test were at acceptable levels. In vivo, the flax meshes showed only mild inflammation, comparable to commercial polypropylene meshes. This study revealed that plant-derived biomaterials can provide a new class of implantable materials that could be used as surgical meshes or for other biomedical applications.

Prophylactic intraperitoneal mesh placement to prevent incisional hernia after stoma reversal: a feasibility study.

BACKGROUND: Incisional hernias in old stoma wounds occur in one-third of former stoma patients and pose a significant clinical problem. Parastomal hernias can be prevented by prophylactic mesh placement; however, no trial results are available for incisional hernia prevention after stoma reversal. In this feasibility study, we explore the safety of placing an intraperitoneal mesh to prevent incisional herniation after temporary stoma reversal. METHODS: Ten patients who underwent a low anterior resection with a deviating double-loop stoma for rectal cancer received an intraperitoneal parastomal mesh at the time of stoma formation. At stoma reversal, laparoscopy was performed and adhesions were scored. After reversal, the mesh defect was closed. Mesh and stoma complications were closely monitored. Incisional herniation was assessed at the 2-year follow-up after stoma reversal using ultrasonography. RESULTS: No infections occurred after mesh placement. After a median of 6 months, stomas were reversed. Laparoscopy could be performed in seven patients; all patients had adhesions (median of 25 % of mesh surface). In three patients, the bowel was involved; one required a laparotomy for bowel mobilization during stoma reversal. No adhesion-related morbidity was noted at any time. Except for one superficial wound infection after stoma reversal, no infectious complications were observed. After a median follow-up of 26 months, no incisional herniations were demonstrated. CONCLUSIONS: Prophylactic mesh placement in temporary stoma formations seems safe and feasible and prevents incisional herniation 2 years after stoma reversal.