Remodeling characteristics and collagen distribution in biological scaffold materials explanted from human subjects after abdominal soft tissue reconstruction: an analysis of scaffold remodeling characteristics by patient risk factors and surgical site classifications.

OBJECTIVE: The study purpose was to evaluate the associations between patient characteristics or surgical site classifications and the histologic remodeling scores of biologic meshes biopsied from abdominal soft tissue repair sites in the first attempt to generate a multivariable risk-prediction model of nonconstructive remodeling. BACKGROUND: Host characteristics and surgical site assessments may predict remodeling degree for biologic meshes used to reinforce abdominal tissue repair sites. METHODS: Biologic meshes were biopsied from the abdominal tissue repair sites of n = 40 patients during an abdominal reexploration, stained with hematoxylin and eosin, and evaluated according to a semi-quantitative scoring system for remodeling characteristics (cell types, cell infiltration, extracellular matrix deposition, scaffold degradation, fibrous encapsulation, and neovascularization) and a mean composite score. Biopsies were stained with Sirius Red and Fast Green and analyzed to determine the collagen I:III ratio. On the basis of univariate analyses between subject clinical characteristics or surgical site classification and the histologic remodeling scores, cohort variables were selected for multivariable regression models using P ≤ 0.200. RESULTS: The model selection process for cell infiltration score yielded 2 variables: age at mesh implantation and mesh classification (C statistic = 0.989). For the mean composite score, the model selection process yielded 2 variables: age at mesh implantation and mesh classification (r = 0.449). CONCLUSIONS: These preliminary results constitute the first steps in generating a risk-prediction model that predicts the patients and clinical circumstances most likely to experience nonconstructive remodeling of abdominal tissue repair sites with biologic mesh reinforcement.

Evaluation of absorbable mesh fixation devices at various deployment angles.

BACKGROUND: Hernia repair failure may occur due to suboptimal mesh fixation by mechanical constructs before mesh integration. Construct design and acute penetration angle may alter mesh-tissue fixation strength. We compared acute fixation strengths of absorbable fixation devices at various deployment angles, directions of loading, and construct orientations. METHODS: Porcine abdominal walls were sectioned. Constructs were deployed at 30°, 45°, 60°, and 90° angles to fix mesh to the tissue specimens. Lap-shear testing was performed in upward, downward, and lateral directions in relation to the abdominal wall cranial-caudal axis to evaluate fixation. Absorbatack™ (AT), SorbaFix™ (SF), and SecureStrap™ in vertical (SSV) and horizontal (SSH) orientations in relation to the abdominal wall cranial-caudal axis were tested. Ten tests were performed for each combination of device, angle, and loading direction. Failure types and strength data were recorded. ANOVA with Tukey-Kramer adjustments for multiple comparisons and χ (2) tests were performed as appropriate (p < 0.05 considered significant). RESULTS: At 30°, SSH and SSV had greater fixation strengths (12.95, 12.98 N, respectively) than SF (5.70 N; p = 0.0057, p = 0.0053, respectively). At 45°, mean fixation strength of SSH was significantly greater than SF (18.14, 11.40 N; p = 0.0002). No differences in strength were identified at 60° or 90°. No differences in strength were noted between SSV and SSH with different directions of loading. No differences were noted between SS and AT at any angle. Immediate failure was associated with SF (p < 0.0001) and the 30° tacking angle (p < 0.01). CONCLUSIONS: Mesh-tissue fixation was stronger at acute deployment angles with SS compared to SF constructs. The 30° angle and the SF device were associated with increased immediate failures. Varying construct and loading direction did not generate statistically significant differences in the fixation strength of absorbable fixation devices in this study.

Effect of acellular human dermis buttress on laparoscopic hiatal hernia repair.

PURPOSE: The objective of this study was to evaluate the performance of acellular human dermis reinforcement during laparoscopic hiatal hernia repair. METHODS: A prospective non-randomized, single institution study enrolled patients undergoing laparoscopic hiatal hernia repair. Acellular human dermis, FlexHD (Musculoskeletal Transplant Foundation, Edison, NJ) or AlloDerm (LifeCell Inc., Branchburg, NJ) were used to buttress the repair after primary closure. A protocol barium swallow (BAS) was performed at 6 months and then as needed due to clinical indications. Primary outcome measure was recurrence. Patients completed preoperative and postoperative GERD symptom questionnaires and quality of life surveys (SF-36). Kruskal-Wallis ANOVA, Student's t test, Fisher's exact test, or Wilcoxon signed-rank test were utilized as appropriate (p < 0.05 considered statistically significant). RESULTS: Fifty-four patients (10 men and 44 women) with a mean age of 62 ± 10 years underwent laparoscopic hiatal hernia repair using Flex HD (n = 37) or AlloDerm (n = 17). Both groups were similar with respect to gender, age, hiatus size, hernia type [sliding/Type I (n = 14) or paraesophageal/Type III/IV (n = 40)], esophageal motor function (manometry), preoperative SF-36 quality of life surveys, and GERD symptom questionnaires. Forty-seven patients (87 %) completed the BAS at 6 months; each group had two recurrences (p = 0.597). At median follow-up of 33 months, there were 3 recurrences (18 %) in the AlloDerm group and 5 recurrences (14 %) in the Flex HD group (p = 0.365). Minimal differences in GERD symptoms or SF-36 scores were detected between groups. However, anti-reflux medication usage, GERD symptoms, and quality of life significantly improved for both groups after laparoscopic hiatal hernia repair. CONCLUSIONS: Laparoscopic hiatal hernia repair with acellular human dermis reinforcement results in improvement of GERD-related symptoms and quality of life without mesh-associated complications. The type of acellular human dermis did not influence recurrence rate.

Remodeling Characteristics and Collagen Distributions of Biologic Scaffold Materials Biopsied From Postmastectomy Breast Reconstruction Sites.

OBJECTIVE: The study purpose was to evaluate the associations between patient characteristics and the histologic remodeling scores of acellular dermal matrices (ADMs) biopsied from breast reconstruction sites in the first attempt to generate a multivariable risk prediction model of nonconstructive remodeling. It was hypothesized that host characteristics and surgical site assessments predict the degree of graft remodeling for ADMs used during breast reconstruction. METHODS: The ADMs were biopsied from the breast reconstruction sites of n = 62 patients during a subsequent breast procedure, stained with hematoxylin-eosin, and evaluated according to a semi-quantitative scoring system for remodeling characteristics (cell types, cell infiltration, extracellular matrix deposition, scaffold degradation, fibrous encapsulation, and neovascularization) and a mean composite score. Biopsies were stained with Sirius Red and Fast Green, and analyzed to determine the collagen I:III ratio. Based on univariate analyses between subject clinical characteristics and the histologic remodeling scores, cohort variables were selected for multivariable regression models using a P value of 0.20 or less. RESULTS: The composite score model yielded 3 variables: pack-year history, corticosteroid use, and radiation timing (r pseudo = 0.81). The model for collagen I yielded 2 variables: corticosteroid use and reason for reoperation (r pseudo = 0.78). The model for collagen III yielded 1 variable: reason for reoperation (r pseudo = 0.35). CONCLUSIONS: These preliminary results constitute the first steps in generating a risk prediction model that predicts the patients and clinical circumstances most likely to experience nonconstructive remodeling of biologic grafts used to reconstruct the breast.

A material cost-minimization analysis for hernia repairs and minor procedures during a surgical mission in the Dominican Republic.

INTRODUCTION: Expenditures on material supplies and medications constitute the greatest per capita costs for surgical missions. We hypothesized that supply acquisition at non-profit organization (NPO) costs would lead to significant cost-savings compared with supply acquisition at US academic institution costs from the provider perspective for hernia repairs and minor procedures during a surgical mission in the Dominican Republic. METHODS: Items acquired for a surgical mission were uniquely QR-coded for accurate consumption accounting. Both NPO and US academic institution unit costs were associated with each item in an electronic inventory system. Medication doses were recorded and QR codes for consumed items were scanned into a record for each sampled procedure. Mean material costs and cost-savings ± SDs were calculated in US dollars for each procedure type. Cost-minimization analyses between the NPO and the US academic institution platforms for each procedure type ensued using a two-tailed Wilcoxon matched-pairs test with α = 0.05. Item utilization analyses generated lists of most frequently used materials by procedure type. RESULTS: The mean cost-savings of supply acquisition at NPO costs for each procedure type were as follows: $482.86 ± $683.79 for unilateral inguinal hernia repair (n = 13); $332.46 ± $184.09 for bilateral inguinal hernia repair (n = 3); $127.26 ± $13.18 for hydrocelectomy (n = 9); $232.92 ± $56.49 for femoral hernia repair (n = 3); $120.90 ± $30.51 for umbilical hernia repair (n = 8); $36.59 ± $17.76 for minor procedures (n = 26); and $120.66 ± $14.61 for pediatric inguinal hernia repair (n = 7). CONCLUSION: Supply acquisition at NPO costs leads to significant cost-savings compared with supply acquisition at US academic institution costs from the provider perspective for inguinal hernia repair, hydrocelectomy, umbilical hernia repair, minor procedures, and pediatric inguinal hernia repair during a surgical mission in the Dominican Republic. Item utilization analysis can generate minimum-necessary material lists for each procedure type to reproduce cost-savings for subsequent missions.

Remodeling characteristics and collagen distribution in synthetic mesh materials explanted from human subjects after abdominal wall reconstruction: an analysis of remodeling characteristics by patient risk factors and surgical site classifications.

BACKGROUND: The purpose of this study was to evaluate the associations between patient characteristics or surgical site classifications and the histologic remodeling scores of synthetic meshes biopsied from their abdominal wall repair sites in the first attempt to generate a multivariable risk prediction model of non-constructive remodeling. METHODS: Biopsies of the synthetic meshes were obtained from the abdominal wall repair sites of 51 patients during a subsequent abdominal re-exploration. Biopsies were stained with hematoxylin and eosin, and evaluated according to a semi-quantitative scoring system for remodeling characteristics (cell infiltration, cell types, extracellular matrix deposition, inflammation, fibrous encapsulation, and neovascularization) and a mean composite score (CR). Biopsies were also stained with Sirius Red and Fast Green, and analyzed to determine the collagen I:III ratio. Based on univariate analyses between subject clinical characteristics or surgical site classification and the histologic remodeling scores, cohort variables were selected for multivariable regression models using a threshold p value of ≤0.200. RESULTS: The model selection process for the extracellular matrix score yielded two variables: subject age at time of mesh implantation, and mesh classification (c-statistic = 0.842). For CR score, the model selection process yielded two variables: subject age at time of mesh implantation and mesh classification (r (2) = 0.464). The model selection process for the collagen III area yielded a model with two variables: subject body mass index at time of mesh explantation and pack-year history (r (2) = 0.244). CONCLUSION: Host characteristics and surgical site assessments may predict degree of remodeling for synthetic meshes used to reinforce abdominal wall repair sites. These preliminary results constitute the first steps in generating a risk prediction model that predicts the patients and clinical circumstances for which non-constructive remodeling of an abdominal wall repair site with synthetic mesh reinforcement is most likely to occur.

Differentiation of biologic scaffold materials through physicomechanical, thermal, and enzymatic degradation techniques.

OBJECTIVE: The objective of this study was to characterize the physicomechanical, thermal, and degradation properties of several types of biologic scaffold materials to differentiate between the various materials. BACKGROUND: As more biologic scaffold materials arrive on the market, it is critical that surgeons understand the properties of each material and are provided with resources to determine the suitability of these products for specific applications such as hernia repair. METHODS: Twelve biologic scaffold materials were evaluated, including crosslinked and non-crosslinked; those of bovine, human, and porcine origin; and derivatives of pericardium, dermis, and small intestine submucosa. Physicomechanical, thermal, and degradation properties were evaluated through biomechanical testing, modulated differential scanning calorimetry, and collagenase digestion assays, respectively. Biomechanical testing included suture retention, tear strength, uniaxial tensile, and ball burst techniques. RESULTS: All scaffolds exhibited suture retention strengths greater than 20 N, but only half of the scaffolds exhibited tear resistance greater than 20 N, indicating that some scaffolds may not provide adequate resistance to tearing. A wide range of burst strengths were observed ranging from 66.2 ± 10.8 N/cm for Permacol to 1,028.0 ± 199.1 N/cm for X-Thick AlloDerm, and all scaffolds except SurgiMend, Strattice, and CollaMend exhibited strains in the physiological range of 10% to 30% (at a stress of 16 N/cm). Thermal analysis revealed differences between crosslinked and non-crosslinked materials with crosslinked bovine pericardium and porcine dermis materials exhibiting a higher melting temperature than their non-crosslinked counterparts. Similarly, the collagenase digestion assay revealed that crosslinked bovine pericardium materials resisted enzymatic degradation significantly longer than non-crosslinked bovine pericardium. CONCLUSIONS: Although differences were observed because of cross-linking, some crosslinked and non-crosslinked materials exhibited very similar properties. Variables other than cross-linking, such as decellularization/sterilization treatments or species/tissue type also contribute to the properties of the scaffolds.

Comparison of laparoscopic skills performance between single-site access (SSA) devices and an independent-port SSA approach.

BACKGROUND: This study compared the performance of validated laparoscopic tasks on four commercially available single-site-access (SSA) devices with the performance of those tasks on an independent-port (IP) SSA setup. METHODS: A prospective, randomized comparison of laparoscopic skills performance on four access devices (ADs) (GelPOINT, SILS Port, SSL Access System, TriPort) and one IP-SSA setup was conducted. A laparoscopic trainer box was used to train 18 (2nd- to 4th-year) medical students, four surgical residents, and five attending surgeons to proficiency in multiport laparoscopy using four laparoscopic drills (i.e., peg transfer, bean drop, pattern cutting, extracorporeal suturing). Drills then were performed in random order on each IP-SSA and AD-SSA setup using straight laparoscopic instruments. Repetitions were timed and errors recorded. Data are presented as mean ± standard deviation. Statistical analysis was performed by two-way analysis of variance (ANOVA) with Tukey HSD post hoc tests. RESULTS: The attending surgeons had significantly faster total task times than the residents or students (P < 0.001), but the difference between the residents and students was not significant. Pair-wise comparisons showed significantly faster total task times for the IP-SSA setup than for all four AD-SSAs within the student group only (P < 0.05). The total task times for the residents and attending surgeons showed a similar profile, but the differences were not significant. When the data for the three groups were combined, the total task time was less for the IP-SSA setup than for each of the four AD-SSA setups (P < 0.001). Similarly, the IP-SSA setup was significantly faster than three of the four AD-SSA setups for peg transfer, three of the four setups for pattern cutting, and two of the four setups for suturing. No significant differences in error rates between the IP-SSA and AD-SSA setups were detected. CONCLUSIONS: Compared with an IP-SSA laparoscopic setup, AD-SSAs are associated with longer task performance times in a trainer box model, independently of the level of training. Task performance was similar across the different SSA devices.

Development of novel electrospun absorbable polycaprolactone (PCL) scaffolds for hernia repair applications.

INTRODUCTION: Permanent/nonresorbable hernia repair materials rely on profibrotic wound healing, and repair sites are commonly composed of disorganized tissue with inferior mechanical strength and risk of reherniation. Resorbable electrospun scaffolds represent a novel class of biomaterials, which may provide a unique platform for the design of advanced soft tissue repair materials. These materials are simple, inexpensive, nonwoven materials composed of polymer fibers that readily mimic the natural extracellular matrix. The primary goal of the present study was to evaluate the physiomechanical properties of novel electrospun scaffolds to determine their suitability for hernia repair. Based on previous experimentation, scaffolds possessing ≥ 20 N suture retention strength, ≥ 20 N tear resistance, and ≥ 50 N/cm tensile strength are appropriate for hernia repair. METHODS: Six novel electrospun scaffolds were fabricated by varying combinations of polymer concentration (10-12 %) and flow rate (3.5-10 mL/h). Briefly, poly(ε-caprolactone) (PCL) was dissolved in a solvent mixture and electrospun onto a planar metal collector, yielding sheets with randomly oriented fibers. Physiomechanical properties were evaluated through scanning electron microscopy, laser micrometry, and mechanical testing. RESULTS: Scanning electron micrographs demonstrated fiber diameters ranging from 1.0 ± 0.1 µm (10 % PCL, 3.5 mL/h) to 1.5 ± 0.2 µm (12 % PCL, 4 mL/h). Laser micrometry demonstrated thicknesses ranging from 0.72 ± 0.07 mm (12 % PCL, 10 mL/h) to 0.91 ± 0.05 mm (10 % PCL, 3.5 mL/h). Mechanical testing identified two scaffolds possessing suture retention strengths ≥ 20 N (12 % PCL, 10 mL/h and 12 % PCL, 6 mL/h), and no scaffolds possessing tear resistance values ≥ 20 N (range, 4.7 ± 0.9 N to 10.6 ± 1.8 N). Tensile strengths ranged from 35.27 ± 2.08 N/cm (10 % PCL, 3.5 mL/h) to 81.76 ± 15.85 N/cm (12 % PCL, 4 mL/h), with three scaffolds possessing strengths ≥ 50 N/cm (12 % PCL, 10 mL/h; 12 % PCL, 6 mL/h; 12 % PCL, 4 mL/h). CONCLUSIONS: Two electrospun scaffolds (12 % PCL, 10 mL/h and 12 % PCL, 6 mL/h) possessed suture retention and tensile strengths appropriate for hernia repair, justifying evaluation in a large animal model. Additional studies examining advanced methods of fabrication may further improve the unique properties of these scaffolds, propelling them into applications in a variety of clinical settings.

Effect of enzymatic degradation on the mechanical properties of biological scaffold materials.

BACKGROUND: Biological scaffolds must support a complex balance of resisting enzymatic degradation while promoting tissue remodeling. Thus, the purpose of this study was to evaluate the effects of in vitro enzymatic exposure on the mechanical properties of biological scaffolds. It was hypothesized that exposure to an enzyme solution would result in decreased tensile strength and that crosslinked scaffolds would resist enzymatic degradation more effectively than noncrosslinked scaffolds. METHODS: Nine scaffolds were evaluated (four porcine dermis: Permacol™, CollaMend™, Strattice™, XenMatrix™; two human dermis: AlloMax™, FlexHD(®); two bovine pericardium: Veritas(®), PeriGuard(®); and one porcine small intestine submucosa: Surgisis™). Ten specimens (n = 10) were hydrated in saline at 37 °C and subjected to uniaxial testing to establish baseline properties. 50 specimens (n = 50) were incubated in collagenase solution at 37 °C for 2, 6, 12, 24, or 30 h (n = 10 each group) followed by uniaxial tensile testing. RESULTS: Tensile strength was significantly reduced after 30 h for CollaMend™, AlloMax™, Veritas(®), Strattice™, XenMatrix™, Permacol™, and FlexHD(®) (p < 0.01), while PeriGuard(®) demonstrated a slight increase in tensile strength (p = 0.0188). Crosslinked bovine pericardium (PeriGuard(®)) maintained greater tensile strength than noncrosslinked bovine pericardium (Veritas(®)) throughout all exposure periods (p < 0.0001). Similarly, crosslinked porcine dermis (Permacol™) maintained greater tensile strength than noncrosslinked porcine dermis (Strattice™ and XenMatrix™) throughout all exposure periods (p < 0.0001). CONCLUSIONS: Materials that deteriorate rapidly after in vitro enzymatic exposure may also deteriorate rapidly in vivo, particularly when exposed to a wound environment with elevated levels of matrix metalloproteinases. Permacol™, CollaMend™, Strattice™, FlexHD(®), and PeriGuard(®) survived the longest incubation period (30 h) and withstood mechanical testing. XenMatrix™, AlloMax™, Veritas(®), and Surgisis™ degraded more quickly and did not survive the longer exposure periods. Scaffolds that maintain strength characteristics after in vitro collagenase exposure may be advantageous for long-term hernia repair scenarios where elevated enzyme levels are expected.

Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

BACKGROUND: The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. METHODS: A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. RESULTS: Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH < 4 were not significant between the two groups. Abnormal acid reflux was present in 10 of 24 Dor group patients (41.7%) and in 4 of 19 Toupet patients (21.0%) (p = 0.152). Dysphagia and regurgitation symptom scores improved significantly in both groups compared to preoperative scores. No significant differences in any esophageal symptoms were noted between the two groups preoperatively or at follow-up. SF-36 quality-of-life measures changed significantly from pre- to postoperative for five of ten domains in the Dor group and seven of ten in the Toupet patients (not significant between groups). CONCLUSION: Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

Translational design for limited resource settings as demonstrated by Vent-Lock, a 3D-printed ventilator multiplexer.

BACKGROUND: Mechanical ventilators are essential to patients who become critically ill with acute respiratory distress syndrome (ARDS), and shortages have been reported due to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS: We utilized 3D printing (3DP) technology to rapidly prototype and test critical components for a novel ventilator multiplexer system, Vent-Lock, to split one ventilator or anesthesia gas machine between two patients. FloRest, a novel 3DP flow restrictor, provides clinicians control of tidal volumes and positive end expiratory pressure (PEEP), using the 3DP manometer adaptor to monitor pressures. We tested the ventilator splitter circuit in simulation centers between artificial lungs and used an anesthesia gas machine to successfully ventilate two swine. RESULTS: As one of the first studies to demonstrate splitting one anesthesia gas machine between two swine, we present proof-of-concept of a de novo, closed, multiplexing system, with flow restriction for potential individualized patient therapy. CONCLUSIONS: While possible, due to the complexity, need for experienced operators, and associated risks, ventilator multiplexing should only be reserved for urgent situations with no other alternatives. Our report underscores the initial design and engineering considerations required for rapid medical device prototyping via 3D printing in limited resource environments, including considerations for design, material selection, production, and distribution. We note that optimization of engineering may minimize 3D printing production risks but may not address the inherent risks of the device or change its indications. Thus, our case report provides insights to inform future rapid prototyping of medical devices.

Analysis of standard multiport versus single-site access for laparoscopic skills training.

BACKGROUND: Single-site-access (SSA) laparoscopy is more challenging to perform than multiport (MP) laparoscopy. This study examined the effect of MP versus SSA skills training on laparoscopic performance using surgically naive medical students. METHODS: For the study, 40 medical students at the end of their first year were randomized into two groups. Both groups were trained in four basic laparoscopic drills (peg, rope, bean drop, pattern cutting) using a standard MP setup (group 1) and an SSA approach (group 2). The time and number of repetitions required to attain proficiency were recorded. Each group then crossed over to the alternate approach and repeated the sequence. Data are presented as mean ± standard deviation, and statistical analysis was performed using the two-tailed, unpaired t test. RESULTS: The total times required to attain proficiency for the SSA and MP approaches were not significantly different between the MP-trained group (234.0 ± 114.9 min) and the SSA-trained group (216.4 ± 106.5 min) (p = 0.67). The MP-trained group required less time to reach proficiency on the standard MP setup than the group using the SSA approach (119.1 ± 69.7 vs. 178.0 ± 93.4 min; p = 0.058) and significantly fewer repetitions (77.6 ± 42.6 vs. 118.8 ± 54.3; p = 0.027). The SSA-trained group required significantly less time to reach proficiency on the MP setup than the standard MP-trained group (38.4 ± 29.4 vs. 119.1 ± 69.7 min; p = 0.0013) and needed only a mean of 26.9 repetitions. When the standard MP trainees crossed over to the SSA setup, they required significantly less time to reach proficiency with the SSA approach than the SSA-trained group (114.8 ± 50.5 vs. 178.0 ± 93.4 min; p = 0.026) but required more repetitions than with the MP approach (86.2 ± 35.2 vs. 77.6 ± 42.6; nonsignificant difference). CONCLUSIONS: Laparoscopic SSA skills training results in longer times and more repetitions to achieve proficiency than MP training, but the skills acquired transfer well to the MP approach.

Biomechanical evaluation of potential damage to hernia repair materials due to fixation with helical titanium tacks.

BACKGROUND: This study aimed to determine whether the strength and extensibility of hernia repair materials are negatively influenced by the application of helical titanium tacks. METHODS: This study evaluated 14 meshes including bare polypropylene, macroporous polytetrafluoroethylene, absorbable barrier, partially absorbable mesh, and expanded polytetrafluoroethylene materials. Each mesh provided 15 specimens, which were prepared in 7.5 × 7.5-cm squares. Of these, 5 "undamaged" specimens were subjected to ball-burst testing to determine their biomechanical properties before application of helical titanium tacks (ProTack). To 10 "damaged" specimens 7 tacks were applied 1 cm apart in a 3.5-cm-diameter circle using a tacking force of 25 to 28 N. The tacks were removed from five of the specimens before ball-burst testing and left intact in the remaining five specimens. RESULTS: The application of tacks had no effect on the tensile strength of Dualmesh, ProLite Ultra, Infinit, Ultrapro, C-QUR Lite (<6 in.), Prolene Soft, or Physiomesh, but the tensile strengths were reduced for Bard Mesh, C-QUR, ProLite, and C-QUR Lite (>6 in.). Most of the meshes did not exhibit significantly different tensile strengths between removal of tacks and tacks left intact. Exceptions included C-QUR, Prolene, Ultrapro, and Bard Soft Mesh, which were weaker with removal of tacks than with tacks left intact during the test. Damage due to the application of helical titanium tacks also caused increased strain at a stress of 16 N/cm for all the meshes except C-QUR Lite (>6 in.) and Physiomesh. CONCLUSIONS: Many of the meshes evaluated in this study exhibited damage in the form of reduced tensile strength and increased extensibility after the application of tacks compared with the corresponding "undamaged" meshes. Meshes with smaller interstices and larger filaments were influenced negatively by the application of helical titanium tacks, whereas mesh designs with larger interstices and smaller filaments tended to maintain their baseline mechanical properties.

Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair.

BACKGROUND: This study aimed to compare the physicomechanical properties of composite prostheses for laparoscopic ventral hernia repair (LVHR) through standard testing and a proposed classification system. METHODS: Seven prostheses (four with absorbable barriers and 3 with nonabsorbable barriers) were evaluated. The barrier layer was removed, after which the area of the interstices and the diameter of the filaments were determined. The barrier layer was left intact during thickness, density, suture retention strength, tear resistance, uniaxial tensile, and ball-burst testing. Specimens were oriented parallel or perpendicular to their longest dimension during testing. One-way analysis of variance (ANOVA) with Tukey's posttest or an unpaired, two-tailed t-test was performed to determine whether differences existed due to mesh or orientation, and a p value<0.05 was considered significant. RESULTS: Significant differences were observed between mesh types and due to the orientation of the mesh during testing. Of the absorbable barrier meshes, Bard Sepramesh IP Composite demonstrated the greatest suture retention and tear strengths, followed by C-QUR mesh. Of the permanent barrier meshes, DUALMESH demonstrated the greatest suture retention strength in the perpendicular direction, followed by Bard Composix E/X. DUALMESH and Bard Composix E/X demonstrated equivalent suture retention strength in the parallel direction and equivalent tear resistance in both testing directions. All meshes demonstrated tensile strengths greater than the physiologically relevant range of 16-32 N/cm. CONCLUSIONS: This study provided a basic understanding of how the structural aspects of each mesh design influence functionality. Differences between composite barrier prostheses commonly used for LVHR were observed due to barrier type, mesh type, and orientation. A set of standard testing techniques and a classification system also were presented to define fully the properties of these materials.

Laparoscopic fixation of biologic mesh at the hiatus with fibrin or polyethylene glycol sealant in a porcine model.

BACKGROUND: The objective of this study was to determine the acute and chronic fixation strengths achieved by fibrin or polyethylene glycol (PEG) sealants to secure biologic mesh at the esophageal hiatus in a porcine model. METHODS: For this study, 32 female domestic pigs were divided into four groups of 8 each. The four groups respectively received acute fibrin sealant, acute PEG sealant, chronic fibrin sealant, and chronic PEG sealant. Laparoscopically, a 5.5 × 8.5-cm piece of Biodesign Surgisis Hiatal Hernia Graft (porcine small intestine submucosa) was oriented with the U-shaped cutout around the gastroesophageal junction and the short axis in the craniocaudal direction to simulate hiatal reinforcement with a biologic mesh. The mesh then was secured with 2 ml of either fibrin sealant or PEG sealant. The pigs in the acute groups were maintained alive for 2 h to allow for complete polymerization of the sealants, and the pigs in the chronic group were maintained alive for 14 days. After the pigs were euthanized, specimens of the mesh-tissue interface were subjected to lap shear testing to determine fixation strength, and hematoxylin and eosin (H&E) stained slides were evaluated for evidence of remodeling. RESULTS: No significant differences were observed between the acute and chronic fixation strengths or the remodeling characteristics of the two sealants. However, fixation strength increased significantly over time for both types of sealant. Evidence of remodeling also was significantly more pronounced in the chronic specimens than in the acute specimens. CONCLUSIONS: This study demonstrated the feasibility of using fibrin or PEG sealants to secure biologic mesh at the hiatus in a porcine model.

Collagen type I:III ratio of the gastroesophageal junction in patients with paraesophageal hernias.

BACKGROUND: The purpose of this study was to examine the biological environment of the esophageal hiatus through analysis of the collagen content within the gastrohepatic ligament (GHL), gastrophrenic ligament (GPL), and phrenoesophageal ligament (PEL) in patients with type I hiatal hernias (HH) and type III paraesophageal hernias (PEH). METHODS: A control group (N=10) and patients with type I HH (N=10) and type III PEH (N=10) were included in the analysis. Specimens of the GHL, PEL, and GPL were collected intraoperatively. Slides stained with sirius red/fast green were created and ten photos at 400×magnification were taken of each specimen. Axiovision 4.7 (Zeiss) photo analysis software was employed for quantification of collagen I (red) and III (green) by calculating color area (µm2). Statistical significance (p<0.05) was determined using a one-way ANOVA and Fisher's LSD post-test. RESULTS: Cross-polarization microscopy revealed that the collagen I content was similar in the three study groups for the GHL, greater in the type III PEH group and in the control group compared to the type I HH group for the PEL, and greater in the type III PEH group compared to control group for the GPL. Collagen III quantity was greater in the control group than in the type I HH group for each ligament, and greater in the GHL and PEL when compared to the type III PEH group. Type III PEH patients had greater collagen III quantity than did type I HH patients for each ligament. Collagen type I:III ratio of the GHL was greater in both hernia groups compared to the control group. Type III PEH patients contained a higher I:III ratio than both the control and type I HH groups with respect to the PEL. There was no difference in the ratio with evaluation of the GPL for the three groups. CONCLUSION: Evaluation of the esophageal hiatus revealed that patients with PEH have a different biological environment with regard to collagen content compared to control patients. The collagen I:III ratio of the study groups was equal to or greater than the control group. Collagen deficiency in the GE junction supporting ligaments does not appear to be an etiology of PEH formation.

Evaluation of intraperitoneal placement of absorbable and nonabsorbable barrier coated mesh secured with fibrin sealant in a New Zealand white rabbit model.

BACKGROUND: This study aimed to evaluate the acute and chronic fixation strength of fibrin sealant (FS) as an alternative method of fixation for laparoscopic ventral hernia repair (LVHR). METHODS: Representative mesh types for LVHR included one nonabsorbable barrier mesh (Composix) and three absorbable barrier meshes (Sepramesh, Proceed, and Parietex composite). Macroporous polypropylene mesh (Prolite Ultra) served as the control mesh. Three methods of fixation were used, namely, 0-polypropylene suture+FS (ARTISS 4 IU), FS alone (ARTISS), and tacks alone, to secure 3×4-cm pieces of mesh (10 of each combination) to the peritoneal surface of New Zealand white rabbit abdominal wall. After 2 h of incubation at 37 °C, specimens underwent acute testing. Subsequently, a chronic phase was completed using the aforementioned fixation methods (10 of each combination), in which two 4×4-cm pieces of mesh were secured intraperitoneally in each of 75 New Zealand white rabbits, which survived 8 weeks until they were sacrificed. A transparent grid overlay was used to measure the mesh and adhesion area. Adhesion tenacity was characterized using the Garrard adhesion scale. In both the acute and chronic samples, a 3×3-cm area of mesh-tissue interface underwent lap shear testing at a rate of 0.42 mm/s using a tensiometer (Instron 5542). The maximum load sustained by the mesh-tissue construct was recorded as the acute fixation strength in newtons (N). Data are given as means±standard error of the mean. Statistical significance (p<0.05) was determined using a one-way analysis of variance (ANOVA) with Fisher's least significant difference (LSD) posttest or a nonparametric Kruskal-Wallis test (adhesion scores). RESULTS: The acute fixation strength was significantly greater for all the meshes secured with either suture+FS or tacks alone than for FS alone (p<0.001 for all comparisons). All the meshes except Proceed demonstrated greater acute fixation strength with suture+FS than with tacks alone (p≤0.016). Composix achieved greater acute fixation with suture+FS than all the other meshes (p≤0.022). Acute fixation with suture + FS was greater for Parietex Composite and ProLite Ultra than for Proceed (p≤0.015). When the animals were sacrificed, 48 of 50 meshes fixed with FS alone were insufficiently affixed to the abdominal wall, which may have resulted in hernia recurrence in a hernia model. The chronic fixation strength was greater for all the mesh types with either suture+FS or tacks only than with FS alone (p≤0.0005). The chronic fixation strength was greater with suture+FS than with tacks for Proceed and ProLite Ultra (p≤0.013). Neither mesh area nor adhesion tenacity differed significantly with any mesh/fixation method combination. CONCLUSIONS: In a chronic rabbit model of LVHR, fixation strength with FS alone was inadequate for selected nonabsorbable and absorbable barrier-coated meshes. The acute and chronic fixation strengths of suture+FS were equivalent or superior to the fixation strength of tacks alone. Using a combination of suture and FS for mesh fixation in LVHR may provide adequate fixation while decreasing postoperative pain due to spiral titanium tacks. In this preclinical series, mesh secured to the peritoneal surface by FS alone may have led to early recurrence.

Clinical outcomes of atypical extra-esophageal reflux symptoms following laparoscopic antireflux surgery.

INTRODUCTION: While it is well established that antireflux surgery is effective in relieving typical gastroesophageal reflux disease (GERD) symptoms such as heartburn and regurgitation, it is currently unclear whether atypical symptoms (cough, hoarseness, wheeze) foreshadow a less satisfactory outcome following laparoscopic antireflux surgery (LARS). The purpose of this study is to critically analyze the clinical outcomes of atypical symptoms in patients undergoing LARS. METHODS: Patients scheduled for LARS for GERD were prospectively enrolled over a 7-year period; all subjects underwent preoperative high-resolution manometry (HRM) and had evidence of GERD on ambulatory pH study. Cough, wheeze, and hoarseness were considered atypical symptoms. During preoperative and postoperative examinations, patients completed detailed foregut symptomatology questionnaires, using both 5-point Likert and 10-point visual analog scales (VAS) to document typical as well as atypical symptoms. Atypical symptom burden was calculated as a sum of VAS for the three atypical symptoms, termed the atypical score (ATS). HRM patterns were grouped into normal, spastic, and hypomotile. Statistical significance (p < 0.05) was determined using paired t-test, and analysis of variance with post hoc least significant difference (LSD). RESULTS: One hundred thirteen patients (age 49 ± 1.26 years, range 20-84 years, M:F 47:66) with mean follow-up of 28 ± 2.31 months (range 1-92 months) fulfilled inclusion criteria, having mean modified DeMeester score of 45.5 ± 2.78. Heartburn was noted in 84.1%, while atypical symptoms of some degree were reported by 92.0% (104 patients). Heartburn improved from a preoperative score of 7.1 ± 0.54 to 0.9 ± 0.24 after LARS, and ATS improved from 8.9 ± 0.71 to 2.2 ± 0.42. Significant improvements were noted for all atypical symptoms analyzed (p < 0.0001 for each). Improvement in atypical symptoms was least in the presence of hypomotility features on HRM (21.7% improvement), compared with normal motility (72.4%) and spastic features (83.9%). Preoperative atypical score (p < 0.0001) and esophageal hypomotility (p = 0.04) demonstrated a linear relationship with postoperative atypical score. CONCLUSIONS: In an unselected cohort of patients undergoing LARS, atypical GERD symptoms improved as significantly as typical symptoms. Symptom improvement was significantly lower in the presence of esophageal hypomotility and with higher symptomatic state. Therefore, patients with severe atypical symptoms or hypomotile esophagus may not achieve the same clinical satisfaction from LARS.

Prospective evaluation of adhesion characteristics to intraperitoneal mesh and adhesiolysis-related complications during laparoscopic re-exploration after prior ventral hernia repair.

BACKGROUND: The purpose of this study was to characterize the adhesion characteristics of absorbable- and nonabsorbable-barrier-coated meshes and to report adhesiolysis-related complications during laparoscopic re-exploration after prior ventral hernia repair. METHODS: Under an IRB-approved protocol, patients undergoing laparoscopic re-exploration after prior intraperitoneal mesh placement were prospectively graded intraoperatively for adhesion tenacity (0-4), adhesion surface area (0 = 0%, 10 = 100%), and ratio of adhesiolysis time to mesh surface area (min/cm(2)). Adhesiolysis-related complications were also recorded. Data are given as mean ± SD. Statistical significance (P < 0.05) was determined using the t test and Fisher's exact test. RESULTS: From March 2006 to March 2009, 69 patients underwent laparoscopic surgery after prior intraperitoneal mesh placement for ventral hernia repair. Previous meshes were absorbable-barrier-coated mesh (n = 18), permanent-barrier composite mesh [Composix® (n = 17)], permanent-barrier noncomposite mesh [DualMesh® (n = 14)], uncoated polypropylene mesh (n = 12), and biologic mesh (n = 8). Indications for laparoscopic re-exploration were recurrent ventral hernia (n = 58), chronic pain (n = 3), cholecystectomy (n = 3), parastomal hernia (n = 2), small bowel obstruction (n = 1), nephrectomy (n = 1), and Nissen fundoplication (n = 1). Adhesions to DualMesh were less tenacious (P < 0.05) compared to all other meshes. Surface area of adhesions to DualMesh were less (P < 0.05) than to Composix and to uncoated polypropylene mesh, but not to absorbable-barrier-coated and biologic meshes. Adhesiolysis time:mesh surface area was less (P < 0.05) for DualMesh compared to Composix, uncoated polypropylene, and biologic mesh, but not to absorbable-barrier-coated mesh. Adhesiolysis-related complications occurred in two (16.7%) (P = ns) patients with uncoated polypropylene mesh, one cystotomy and one enterotomy; both were repaired laparoscopically. There were two (16.7%) (P = ns) conversions to an open procedure: one converted patient had Composix (6.7%) and one had absorbable-barrier-coated mesh (5.9%). There were no adhesiolysis-related complications with these meshes. There were no adhesiolysis-related complications or conversions to open in the DualMesh or biologic mesh groups. CONCLUSIONS: Adhesion characteristics of mesh placed intraperitoneally and adhesiolysis-related complications during laparoscopic re-exploration after ventral hernia repair are associated with unique properties of the mesh and/or barrier.