The Efficacy of Liposomal Bupivacaine on Postoperative Pain Following Abdominal Wall Reconstruction: A Randomized, Double-blind, Placebo-controlled Trial.

OBJECTIVE: To study the efficacy of liposomal bupivacaine on postoperative opioid requirement and pain following abdominal wall reconstruction. SUMMARY BACKGROUND DATA: Despite the widespread use of liposomal bupivacaine in transversus abdominis plane block, there is inadequate evidence demonstrating its efficacy in open abdominal wall reconstruction. We hypothesized that liposomal bupivacaine plane block would result in decreased opioid requirements compared with placebo in the first 72 hours after surgery. METHODS: This was a single-center double-blind, placebo-controlled prospective study conducted between July 2018 and November 2019. Adult patients (at least 18 yrs of age) undergoing open, elective, ventral hernia repairs with mesh placed in the retromuscular position were enrolled. Patients were randomized to surgeon-performed transversus abdominis plane block with liposomal bupivacaine, simple bupivacaine, or normal saline (placebo). The main outcome was opioid requirements in the first 72 hours after surgery. Secondary outcomes included total inpatient opioid use, pain scores determined using a 100 mm visual analog scale, length of hospital stay, and patientreported quality of life. RESULTS: Of the 164 patients who were included in the analysis, 57 patients received liposomal bupivacaine, 55 patients received simple bupivacaine, and 52 received placebo. There were no differences in the total opioid used in the first 72 hours after surgery as measured by morphine milligram equivalents when liposomal bupivacaine was compared with simple bupivacaine and placebo (325 ± 225 vs 350 ± 284 vs 310 ± 272, respectively, P = 0.725). Similarly, there were no differences in total inpatient opioid use, pain scores, length of stay, and patient-reported quality of life. CONCLUSIONS: There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared with simple bupivacaine and placebo for open abdominal wall reconstruction.

Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research.

BACKGROUND: Randomized controlled trials (RCTs) are the gold standard to establish evidence for surgical practice but can be hindered by high costs, complexity, and time requirements. Recently, observational registries have been leveraged as platforms for clinical trials to address these limitations, though few registry-based surgical RCTs have been conducted. Here, we present our group's approach to surgical registry-based RCTs and early results. MATERIALS AND METHODS: To facilitate these trials, we focused on registry integration into surgeons' workflows, routine collection of patient-reported outcomes at clinic visits, and pragmatic trial design featuring broad inclusion criteria and standard of care follow-up. These features maximize generalizability and facilitate follow-up by minimizing visits and tests outside of normal practice. RESULTS: Since 2017, our group has completed enrollment in 4 registry-based RCTs with another 5 trials ongoing. Of these, 4 trials have been multicenter. Over 1000 patients have been enrolled in these studies, with follow-up rates of 90% or greater. Most of these trials are on track to complete enrollment in approximately 2 y from their start date. Beyond salary support, resource utilization is low. None of our trials has been terminated due to lack of resources or futility. CONCLUSIONS: Registry-based RCTs allow for efficient conduct of pragmatic surgical trials. Thoughtful study design, registry integration into surgeons' routines, and a team culture embracing research are paramount. We believe registry-based trials are the future of affordable, high-level, prospective surgical research.

Laparoscopic splenectomy for immune thrombocytopenia (ITP): long-term outcomes of a modern cohort.

BACKGROUND: The advent of newer second-line medical therapies (SLMT) for immune thrombocytopenia (ITP) has contributed to decreased rates of splenectomy, following a trend to avoid or delay surgery. We aimed to characterize the long-term outcomes of laparoscopic splenectomy (LS) for ITP at our institution, examining differences in LS efficiency when performed before or after SLMTs. METHODS: Adults with primary ITP who underwent LS between 2002 and 2016 were identified. Retrospective review of electronic medical records was supplemented with telephone interviews. Treatment response was defined according to current guidelines as complete responders (CR), responders (R), and non-responders (NR). Kaplan-Meier estimates assessed relapse-free rates, and predictors of long-term response were investigated using logistic regression. RESULTS: 109 patients met inclusion criteria, from which 42% were treated with an SLMT before referral to LS. LS was completed in all cases, with no conversions or intraoperative complications. The perioperative morbidity was 7.3%, including 3 deep vein and 2 portal vein thrombosis, one reoperation for bleeding, and no mortalities. Splenectomy was initially effective in 99 patients (CR + R = 90.8%), and 10 patients were NR. At a median 62-month follow-up, 25 patients relapsed, resulting in a 68% CR + R rate. Proportion of CR + R was similar in patients who previously received SLMT and those who did not (61 vs. 76.7%, p = 0.08). CR + R patients were younger (45 vs. 53, p = 0.03), had higher preoperative platelet counts (36 vs. 19, p = 0.01), and experienced a higher increment in platelet counts during hospital stay (117 vs. 38, p < 0.001) as well as 30-days postoperatively (329 vs. 124, p < 0.001). Only a robust response in platelet count at 30-days postoperatively was independently associated with long-term response (OR 1.005, p = 0.006). CONCLUSION: LS was curative in 68% of patients, with no statistically significant difference when performed before or after SLMTs. Outcomes remain challenging to predict preoperatively, with only a robust increase in platelet counts on short term being associated with long-term response.

Hernia 3D training model: a new inguinal hernia 3D-printed simulator.

OBJECTIVE: Barros et al. demonstrated a 3D printed model that exhibits anatomical representativeness, low cost, and scalability. The model was created based on subtraction data obtained from computed tomography scans. Images were modeled and reconstructed in 3D to display the male inguinal region, typically viewed using a laparoscopic approach. To evaluate the functionality and quality of the anatomical representation of the hernia 3D training model. METHODS: A model was created based on subtraction data derived from computed tomography scans of the pelvic bones and lumbar spine using the Blender 3.2.2 software program. Images were modeled and reconstructed in 3D to display the male inguinal region, typically viewed using a laparoscopic approach. Polylactic acid plastic was used to print the model. Some structures were made using ethylene vinyl acetate to enable possible material replacement and model reutilization. Thirty surgeons with various training levels were invited to use the model. Transabdominal inguinal hernioplasty was performed by simulating the same steps as those of a laparoscopic surgery, and the surgeons answered a questionnaire regarding the simulation. RESULTS: Twenty-eight surgeons responded, seven of whom were experts in the treatment of abdominal wall hernias. The model was deemed easy to use, realistic, and anatomically precise, establishing it as a valuable supplement to minimally invasive surgery training. CONCLUSION: The evaluation of this 3D model was favorable, as it accurately depicted the inguinal region anatomically, while also proving to be cost-effective for training purposes. The model could be a good option, particularly beneficial for training surgeons at the beginning of their careers.

Short-term outcomes of robotic inguinal hernia repair during robotic prostatectomy - An analysis of the Abdominal Core Health Quality Collaborative.

BACKGROUND: Concomitant robotic-assisted laparoscopic prostatectomy (RALP) and robotic inguinal hernia repair (RIHR) has been reported. Nevertheless, data on its safety is lacking and some surgeons avoid performing both operations concurrently due to the potential risk of mesh related complications in the setting of a fresh vesicourethral anastomosis. We aimed to investigate differences in 30-day outcomes between patients undergoing RALP+RIHR and those undergoing RIHR alone. METHODS: Patients who have undergone concomitant RALP and RIHR with 30-day follow-up available were identified within the Abdominal Core Health Quality Collaborative. Using a propensity score algorithm, they were matched with a cohort of patients undergoing RIHR alone based on confounders such as body mass index, age, ASA class, smoking, hernia size and recurrent status and prior pelvic operation. The groups were compared for 30-day rates of surgical site infection (SSI), surgical site occurrences (SSO), surgical site occurrences requiring operative intervention (SSOPI) and hernia recurrence. RESULTS: 24 patients underwent RALP + RIHR and were matched to 72 patients who underwent RIHR alone (3:1). Median age was 64 years, 33% were obese and 17% smokers. No significant differences were found on 30-day rates of overall complications (21% RALP + RIHR vs. 15% RIHR, p = 0.53) and surgical site occurrences (12% RALP + RIHR vs.11% RIHR, p = 0.85). No patient in the RALP + RIHR group had a 30-day SSI, SSOPI or early recurrence. CONCLUSION: RALP+RIHR appears not to result in increased rates of wound complications, overall complications or early recurrence when compared to patient undergoing RIHR alone. Prospective, controlled studies with larger number of patients are needed to confirm our findings.

Biologic versus synthetic mesh in open ventral hernia repair: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Ventral hernia repair is one of the most common operations performed worldwide, and using mesh is standard of care to decrease recurrence. Biologic meshes are increasingly used to minimize complications associated with synthetic mesh, but with significantly higher cost and unclear efficacy. Until recently, most of the evidence supporting the use of biologic meshes was from retrospective cohorts with high heterogeneity and risk of bias. We aimed to report a meta-analysis of randomized controlled trials comparing the outcomes of synthetic and biologic mesh in elective open ventral hernia repair. METHODS: A literature search of PubMed, Embase, and Cochrane Library databases was performed to identify randomized controlled trials comparing biologic and synthetic mesh in elective open ventral hernia repairs. The postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: A total of 1,090 studies were screened, and 22 were fully reviewed. Four randomized controlled trials and 632 patients were included in the meta-analysis. Fifty-eight percent of patients had contaminated wounds (Wound Classification II-IV). Hernia recurrence (odds ratio 2.75; 95% confidence interval 1.76-4.31; P < .00001; I2 = 0%) and surgical site infections (odds ratio 1.53; 95% confidence interval 1.02-2.29; P = .04; I2 = 0%) were significantly more common in patients with biologic mesh. The rates of seroma, hematoma, and mesh removal were similar in both groups. CONCLUSION: As compared to synthetic mesh, biologic meshes resulted in increased hernia recurrences and surgical site infections. Current evidence supports macroporous, uncoated synthetic mesh as the implant of choice for elective open ventral hernia repair, and its use should be considered even in contaminated cases.

Body Mass Index Effect on Minimally Invasive Ventral Hernia Repair: A Systematic Review and Meta-analysis.

PURPOSE: Obesity is one of the most important risk factors for complications after ventral hernia repair (VHR), and minimally invasive (MIS) techniques are preferred in obese patients as they minimize wound complications. It is common practice to attempt weight loss to achieve a specific body mass index (BMI) goal; however, patients are often unable to reach it and fail to become surgical candidates. Therefore, we aim to perform a meta-analysis of studies comparing outcomes of obese and nonobese patients undergoing laparoscopic or robotic VHR. PATIENTS AND METHODS: A literature search of PubMed, Scopus, and Cochrane Library databases was performed to identify studies comparing obese and nonobese patients undergoing MIS VHR. Postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: A total of 6483 studies were screened and 26 were thoroughly reviewed. Eleven studies and 3199 patients were included in the meta-analysis. BMI >40 kg/m 2 cutoff analysis included 5 studies and 1533 patients; no differences in hernia recurrence [odds ratios (OR): 1.64; 95% CI: 0.57-4.68; P = 0.36; I2 = 47%), seroma, hematoma, and surgical site infection (SSI) rates were noted. BMI >35 kg/m 2 cutoff analysis included 5 studies and 1403 patients; no differences in hernia recurrence (OR: 1.24; 95% CI: 0.71-2.16; P = 0.58; I2 = 0%), seroma, hematoma, and SSI rates were noted. BMI >30 kg/m 2 cutoff analysis included 4 studies and 385 patients; no differences in hernia recurrence (OR: 2.07; 95% CI: 0.5-8.54; P = 0.32; I2 = 0%), seroma, hematoma, and SSI rates were noted. CONCLUSION: Patients with high BMI undergoing MIS VHR have similar hernia recurrence, seroma, hematoma, and SSI rates compared with patients with lower BMI. Further prospective studies with long-term follow-up and patient-reported outcomes are required to establish optimal management in obese patients undergoing VHR.

Keyhole Versus Sugarbaker Mesh Configuration in Parastomal Hernia Repair: A Systematic Review and Meta-analysis.

BACKGROUND: Parastomal hernia repairs (PHRs) are often complex and challenging, even for experienced abdominal wall surgeons. Although the ideal therapeutic option in the setting of a parastomal hernia is to restore intestinal continuity, this is often not feasible, and numerous techniques have been described for PHR. Current guidelines recommend using mesh for elective PHR, but there is a scarcity of evidence comparing different PHR techniques. We aimed to report a meta-analysis comparing the outcomes of the "Sugarbaker" and "Keyhole" mesh configuration in PHR. METHODS: A literature search of PubMed, Embase, Scopus, and Cochrane Library databases was performed to identify studies comparing Sugarbaker and Keyhole mesh configuration in PHR. Postoperative outcomes were assessed by means of pooled analysis and meta-analysis. Statistical analysis was performed using RevMan 5.4. Heterogeneity was assessed with I2 statistics. RESULTS: A total of 3247 studies were screened, and 27 were fully reviewed. Ten studies and 632 patients were included in the meta-analysis. Three hundred five patients (48.3%) with Keyhole and 327 patients (51.7%) with Sugarbaker mesh configuration. Four hundred thirty-three patients (68.5%) underwent laparoscopic PHR with intraperitoneal onlay mesh. Sugarbaker mesh configuration was associated with lower hernia recurrence compared with Keyhole (odds ratio: 0.39; 95% CI: 0.19-0.83; P = 0.01; I2 = 46%). No differences were seen in overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding. CONCLUSION: PHR with Sugarbaker mesh configuration is associated with decreased hernia recurrence compared with Keyhole and had similar rates of overall complications, reoperations, stoma outlet obstruction, mesh infection, and postoperative bleeding.

Capturing Surgical Data: Comparing a Quality Improvement Registry to Natural Language Processing and Manual Chart Review.

INTRODUCTION: Collecting accurate operative details remains a limitation of surgical research. Surgeon-entered data in clinical registries offers one solution, but natural language processing (NLP) has emerged as a modality for automating manual chart review (MCR). This study aims to compare the accuracy and efficiency of NLP and MCR with a surgeon-entered, prospective registry data in determining the rate of gross bile spillage (GBS) during cholecystectomy. METHODS: Bile spillage rates were abstracted from an institutional, surgeon-entered clinical registry from July 2018 to January 2019. These rates were compared to those documented in the electronic medical record (EMR) using NLP and MCR to determine the sensitivity, specificity, and efficiency of each approach. RESULTS: Of the 782 registry entries, 191 cases (24.4%) had surgeon-reported bile spillage. MCR identified bile spillage in 121 cases (15.6%); however, bile spillage information was either missing or ambiguous in 454 cases (58.1%). NLP identified 99 cases (12.7%) of bile spillage. Data abstraction times for the registry, NLP, and MCR were 3 min, 5 min, and 12 h, respectively. When compared to the registry, MCR was 45% sensitive and 94% specific, while NLP was 27.2% sensitive and 92% specific for detecting bile spillage. These differences were significant (X2 = 19.446, P = < 0.001). CONCLUSION: Operative details, such as GBS, may not be abstracted by NLP or MCR if not clearly documented in the EMR. Clinical registries capture operative details, but they rely on surgeons to input the data.

Effect of Intraoperative Urinary Catheter Use on Postoperative Urinary Retention After Laparoscopic Inguinal Hernia Repair: A Randomized Clinical Trial.

Importance: Urinary catheters are commonly placed during laparoscopic inguinal hernia repair as a presumed protection against postoperative urinary retention (PUR), one of the most common complications following this operation. Data from randomized clinical trials evaluating the effect of catheters on PUR are lacking. Objective: To investigate the effect of intraoperative catheters on PUR after laparoscopic inguinal hernia repair. Design, Setting, and Participants: This 2-arm registry-based single-blinded randomized clinical trial was conducted at 6 academic and community hospitals in the US from March 2019 to March 2021 with a 30-day follow-up period following surgery. All patients who presented with inguinal hernias were assessed for eligibility, 534 in total. Inclusion criteria were adult patients undergoing laparoscopic, elective, unilateral, or bilateral inguinal hernia repair. Exclusion criteria were inability to tolerate general anesthesia and failure to understand and sign the written consent form. A total of 43 patients were excluded prior to intervention. Interventions: Patients in the treatment arm had placement of a urinary catheter after induction of general anesthesia and removal at the end of procedure. Those in the control arm had no urinary catheter placement. Main Outcomes and Measures: PUR rate. Results: Of the 491 patients enrolled, 241 were randomized to catheter placement, and 250 were randomized to no catheter placement. The median (IQR) age was 61 (51-68) years, and 465 participants (94.7%) were male. Overall, 44 patients (9.1%) developed PUR. There was no difference in the rate of PUR between the catheter and no-catheter groups (23 patients [9.6%] vs 21 patients [8.5%], respectively; P = .79). There were no intraoperative bladder injuries. In the catheter group, there was 1 incident of postoperative urethral trauma in a patient who presented to the emergency department with PUR leading to a suprapubic catheter placement. Conclusions and Relevance: Intraoperative urinary catheters did not reduce the risk of PUR after laparoscopic inguinal hernia repair. While their use did not appear to be associated with a high rate of iatrogenic complications, there may be a low rate of catastrophic complications. In patients who voided urine preoperatively, catheter placement did not appear to confer any advantage and thus their use may be reconsidered. Trial Registration: ClinicalTrials.gov Identifier: NCT03835351.

Can Hernia Sac to Abdominal Cavity Volume Ratio Predict Fascial Closure Rate for Large Ventral Hernia? Reliability of the Tanaka Score.

BACKGROUND: The hernia sac to abdominal cavity volume ratio (VR) on abdominal CT was described previously as a way to predict which hernias would be less likely to achieve fascial closure. The aim of this study was to test the reliability of the previously described cutoff ratio in predicting fascial closure in a cohort of patients with large ventral hernias. METHODS: Patients who underwent elective, open incisional hernia repair of 18 cm or larger width at a single center were identified. The primary end point of interest was fascial closure for all patients. Secondary outcomes included operative details and abdominal wall-specific quality-of-life metrics. We used VR as a comparison variable and calculated the test characteristics (ie, sensitivity, specificity, and positive and negative predictive values). RESULTS: A total of 438 patients were included, of which 337 (77%) had complete fascial closure and 101 (23%) had incomplete fascial closure. The VR cutoff of 25% had a sensitivity of 76% (95% CI, 71% to 80%), specificity of 64% (95% CI, 54% to 74%), positive predictive value of 88% (95% CI, 83% to 91%), and negative predictive value of 45% (95% CI, 36% to 53%). The incomplete fascial closure group had significantly lower quality of life scores at 1 year (83.3 vs 52.5; p = 0.001), 2 years (85 vs 33.3; p = 0.003), and 3 years (86.7 vs 63.3; p = 0.049). CONCLUSIONS: In our study, the VR cutoff of 25% was sensitive for predicting complete fascial closure for patients with ratios below this threshold. Although there is a higher likelihood of incomplete fascial closure when VR is ≥ 25%, this end point cannot be predicted reliably. Additional studies should be done to study this ratio in conjunction with other hernia-related variables to better predict this important surgical end point.

Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial.

Importance: Although multiple versions of polypropylene mesh devices are currently available on the market for hernia repair, few comparisons exist to guide surgeons as to which device may be preferable for certain indications. Mesh density is believed to impact patient outcomes, including rates of chronic pain and perception of mesh in the abdominal wall. Objective: To examine whether medium-weight polypropylene is associated with less pain at 1 year compared with heavy-weight mesh. Design, Setting, and Participants: This multicenter randomized clinical trial was performed from March 14, 2017, to April 17, 2019, with 1-year follow-up. Patients undergoing clean, open ventral hernia repairs with a width 20 cm or less were studied. Patients were blinded to the intervention. Interventions: Patients were randomized to receive medium-weight or heavy-weight polypropylene mesh during open ventral hernia repair. Main Outcomes and Measures: The primary outcome was pain measured with the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a. Secondary outcomes included quality of life and pain measured at 30 days, quality of life measured at 1 year, 30-day postoperative morbidity, and 1-year hernia recurrence. Results: A total of 350 patients participated in the study, with 173 randomized to receive heavy-weight polypropylene mesh (84 [48.6%] female; mean [SD] age, 59.2 [11.4] years) and 177 randomized to receive medium-weight polypropylene mesh (91 [51.4%] female; mean [SD] age, 59.3 [11.4] years). No significant differences were found in demographic characteristics (mean [SD] body mass index of 32.0 [5.4] in both groups [calculated as weight in kilograms divided by height in meters squared] and American Society of Anesthesiologists classes of 2-4 in both groups), comorbidities (122 [70.5%] vs 93 [52.5%] with hypertension, 44 [25.4%] vs 43 [24.3%] with diabetes, 17 [9.8%] vs 12 [6.8%] with chronic obstructive pulmonary disease), or operative characteristics (modified hernia grade of 2 in 130 [75.1] vs 140 [79.1] in the heavy-weight vs medium-weight mesh groups). Pain scores for patients in the heavy-weight vs medium-weight mesh groups at 30 days (46.3 vs 46.3, P = .89) and 1 year (30.7 vs 30.7, P = .59) were identical. No significant differences in quality of life (median [interquartile range] hernia-specific quality of life score at 1 year of 90.0 [67.9-96.7] vs 86.7 [65.0-93.3]; median [interquartile range] hernia-specific quality of life score at 30 days, 45.0 [24.6-73.8] vs 43.3 [28.3-65.0]) were found for the heavy-weight mesh vs medium-weight mesh groups. Composite 1-year recurrence rates for patients in the heavy-weight vs medium-weight polypropylene groups were similar (8% vs 7%, P = .79). Conclusions and Relevance: Medium-weight polypropylene did not demonstrate any patient-perceived or clinical benefit over heavy-weight polypropylene after open retromuscular ventral hernia repair. Long-term follow-up of these comparable groups will elucidate any potential differences in durability that have yet to be identified. Trial Registration: ClinicalTrials.gov Identifier: NCT03082391.

Patient perceptions on mesh use in hernia repair: A prospective, questionnaire-based study.

BACKGROUND: There has been increasing media coverage regarding the controversy of using mesh in various operations. At this time, there are no published studies evaluating the potential influence of this controversy on patients' perceptions. Therefore, our study aimed to assess patient perceptions of hernia repair surgery with mesh as well as factors that may influence patient opinions. METHODS: A 16-item questionnaire evaluated each patient's perceptions of the use of mesh in their upcoming hernia repair. The primary outcomes of interest were their level of comfort regarding the possibility of hernia repair surgery with mesh, aversion to hernia surgery with mesh, and positive belief that mesh is a safe product in hernia repair surgery. RESULTS: We included 100 patients presenting for a hernia repair and 100 patients presenting for other operations. Both groups identified the media as their most common influence (37% and 40%, respectively). Factors leading to a high level of comfort regarding the possibility of mesh repair included believing mesh was a safe product (P < .001) and hearing about the advantages of mesh (P = .012) from medical professionals (P = .001). Factors leading to a positive belief that mesh was a safe product included the male sex (P = .015), a high socioeconomic standing (P = .006), and their own personal experience (P = .013). Factors leading to aversion to mesh use included the female sex (P = .006) and hearing about meshes causing mesh-related (P = .028) and wound-related complications (P = .025) as well as chronic pain (.008). CONCLUSION: Despite the high penetration of non-medical information in the population before presentation for medical care, most patients overall do not seem to be opposed to the concept of the use of mesh in a hernia repair, but there are certain factors associated with aversion to the use of mesh that physicians should acknowledge and should address this potential issue.

Biomechanical and adhesion comparison of linea alba prophylactic reinforcement with coated and uncoated three-dimensional T-shaped mesh in rabbits.

PURPOSE: Incisional hernia (IH) is a frequent complication of median laparotomy. The use of prophylactic mesh to reduce IH incidence has gained increasing attention. We hypothesized that in an animal model, linea alba prophylactic reinforcement with a three-dimensional T-shaped polypropylene mesh results in greater abdominal wall resistance. METHODS: Study was performed in 27 rabbits. After abdominal midline incision, animals were divided into three groups according to the laparotomy closure method used: (1)3D T-shaped coated mesh; (2)3D T-shaped uncoated mesh; and (3) closure without mesh. After 4 months, each animal's abdominal wall was resected and tensiometric tests were applied. Results included IH occurrence, adhesions to the mesh, and wound complications. RESULTS: There was no significant difference between the groups in maximum tensile strength (p=0.250) or abdominal wall elongation under maximum stress (p=0.839). One rabbit from the control group developed IH (p=1.00). Small intestine and colon adhesions occurred only in the uncoated mesh group (p<0.001) and the degree of adhesions was higher in this group compared to the coated mesh group (p<0.05). CONCLUSION: Use of the current 3D T-shaped prophylactic mesh model did not result in a significant difference in tensiometric measurements when compared with simple abdominal wall closure in rabbits.

Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair: The RIVAL Randomized Clinical Trial.

Importance: Despite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair. Objective: To determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs. Design, Setting, and Participants: This multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis. Interventions: Standard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair. Main Outcomes and Measures: Main outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection. Results: A total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P < .001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P < .001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P = .004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument. Conclusions and Relevance: Results of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons. Trial Registration: ClinicalTrials.gov Identifier: NCT02816658.

Surgical treatment for chronic postoperative inguinal pain-short term outcomes of a specialized center.

BACKGROUND: Chronic postoperative inguinodynia is a challenging long-term complication after inguinal hernia repair. Surgery may be an option for patients who are refractory to non-operative measures. We aim to evaluate the short-term outcomes of surgical treatment for chronic inguinodynia at our institution. METHODS: Consecutive patients undergoing surgical treatment for chronic groin pain were identified in a prospectively maintained database. Outcomes included operative details, intra- and postoperative complications, pain scores, and patient satisfaction. RESULTS: 29 patients were included in the study. All patients were refractory to multimodal pain management. The median pain score on presentation was 8 (IQR 7-10), and after a median follow-up of 6 months (IQR 4-11), there was a statistically significant reduction in pain scores (median 2, IQR 2-6, p < 0.001). Fifty-five percent of patient were pain free or almost pain free and 93 percent reported they would undergo the same operation again. CONCLUSIONS: Chronic groin pain is a complex problem with no universal solution. In our experience, surgical treatment significantly decreased short-term pain scores.

Biodegradable hyaluronan hydrogel coatings on acellular dermis grafts-A potential strategy to improve biologic graft durability in hernia repair application.

Biologic grafts used in hernia repair undergo rapid cellular infiltration and remodeling, but their premature degradation often results in hernia recurrence. We hypothesize that a temporary barrier that prevents infiltration of acute inflammatory cells into the graft during the initial 4 weeks of implantation could mitigate graft degradation. The purpose of this study is to design tyramine-substituted hyaluronan (THA) hydrogel coatings with tunable degradation properties, as a means to develop a resorbable barrier for human acellular dermis grafts (HADM). THA plugs prepared at different cross-linking densities, by varying cross-linking agent concentration (0.0001-0.0075% H2 O2 ), demonstrated varying rates of in vitro degradation (25 U/mL hyaluronidase, 48 h). Based on these results, HADM grafts were coated with THA at three cross-linking densities (0.0001%, 0.00075%, and 0.003% H2 O2 ) and THA coating degradation was evaluated in vitro (25 U/mL hyaluronidase, 48 h) and in vivo (rat intraperitoneal implantation, 1-4 weeks). THA coatings degraded in vitro and in vivo with the lowest cross-linking density (0.0001% H2 O2 ), generally showing greater degradation as evidenced by significant decrease in coating cross-sectional area. However, all three coatings remained partially degraded after 4 weeks of in vivo implantation. Alternate strategies to accelerate in vivo degradation of THA coatings are required to allow investigation of the study hypothesis. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B:2664-2672, 2019.

Does active smoking really matter before ventral hernia repair? An AHSQC analysis.

BACKGROUND: Many studies implicate active smoking as a risk factor for postoperative wound complications and all 30-day morbidity, but the definitions of inclusion and exclusion criteria as well as outcome parameters are inconsistent. Critically, the ability of large databases and meta-analyses to generate statistically significant associations of active smoking with morbidity do not address whether those relationships are actually clinically meaningful. We investigated this relationship after open ventral hernia repair. STUDY DESIGN: Patients undergoing elective open ventral hernia repair in clean wounds with 30-day follow-up were extracted from the Americas Hernia Society Quality Collaborative. Current smokers (within 30 days of surgery) were 1:1 propensity matched to patients who had never smoked based on demographics, comorbidities, and operative characteristics. Wound complications and all 30-day morbidity were assessed. RESULTS: After matching 418 current smokers to 418 patients who had never smoked, the groups were similar with the exception of minor differences in body mass index (31.4 vs 33.3, P < .001) and incidence of chronic obstructive pulmonary disease (18% vs 6%, P < .001). Rates of surgical site occurrence were greater in active smokers (12.0% vs 7.4%, P = .03) driven by increased rates of wound cellulitis (2.4% vs 1.2%) and seroma (5.5% vs 1.2%); however, rates of surgical site infection (4.1 vs 4.1, P = .98), surgical site occurrences requiring a procedural intervention (6.2% vs 5.0%, P = .43), reoperation (1.9% vs 1.2%, P = .39), and all 30-day morbidity (7.5 vs 6.6, P = .60) were not significantly increased in active smokers. There were no instances of mesh excision. CONCLUSION: Active smoking prior to elective clean OVHR is associated with clinically insignificant differences in wound morbidity. Surgeons allowing perioperative smoking should monitor their outcomes to assure these findings are replicable in their own practice.

Prevalence of posttraumatic stress disorder (PTSD) in patients with an incisional hernia.

BACKGROUND: We investigate the prevalence of PTSD in patients with an incisional hernia presenting for evaluation at our institution. METHODS: Study patients were screened for PTSD using the PCL-5 checklist for DSM-5. Patient-reported quality of life and pain scores were assessed using validated tools (HerQLes and PROMIS Pain Intensity 3a survey). RESULTS: The prevalence of PTSD in 131 patients was 32.1% [95% CI 24%-40%]. Patients screening positive (PTSD+) reported lower quality of life scores on HerQles (17.3 ± 14.3 vs. 47.7 ± 29.6, P < 0.001), and higher pain scores on the PROMIS scale (54.2 ± 9.1 vs. 44.2 ± 10, p < 0.001). PTSD + patients also reported significantly higher numbers of previous hernia repairs and abdominal operations, as well as a higher rate of a history of an open abdomen. CONCLUSION: Our study found a significant prevalence of positive screening for PTSD in patients seeking consultation regarding an incisional hernia. We have begun routine preoperative evaluations by a behavioral medicine specialist to address some of these complex issues in high-risk patients. Other high volume hernia programs caring for this challenging patient population should consider such assessments.

History of surgical site infection increases the odds for a new infection after open incisional hernia repair.

BACKGROUND: It is unclear whether a history of surgical site infection is associated with developing a new infection after subsequent operations. We aim to investigate the impact of an earlier abdominal wall surgical site infection on future 30-day infectious wound complications after open incisional hernia repair with mesh. METHODS: Patients undergoing elective, clean open incisional hernia repair were identified within the Americas Hernia Society Quality Collaborative and were divided into those with and without a history of a surgical site infection. Predictors of a surgical site infection and a surgical site infection requiring a procedural intervention were investigated using logistic regression and propensity-matched analysis. A subgroup analysis was done to investigate whether an earlier methicillin-resistant Staphylococcus aureus surgical site infection specifically increases odds for infectious complications. RESULTS: Of 3,168 identified patients, 589 had a history of a surgical site infection and experienced higher rates of postoperative surgical site infection (6.5% vs 2.9%, P < .001) and surgical site infections requiring procedural intervention (5.3% vs 1.9%, P < .001). After adjusting for identified confounders, a previous surgical site infection was independently associated with developing another surgical site infection (odds ratio 2.04, 95% confidence interval 1.32-3.10, P < .001) and a surgical site infection requiring procedural intervention (odds ratio 2.2, 95% confidence interval 1.35-3.55, P = .001). Propensity-matched analysis controlling for additional confounders confirmed the association of an earlier surgical site infection with the outcomes of interest (odds ratio 2.1 and 2.8, respectively). A subgroup analysis found that an earlier methicillin-resistant Staphylococcus aureus infection specifically did not incur higher rates of surgical site infection when compared with non-methicillin-resistant Staphylococcus aureus pathogens. CONCLUSION: History of a surgical site infection increases the odds for new infectious complications after open incisional hernia repair in a clean wound. Investigations on perioperative interventions to ameliorate the negative impact of such association are necessary.