The association of permanent versus absorbable fixation on developing chronic post-herniorrhaphy groin pain in patients undergoing laparoscopic inguinal hernia repair.

INTRODUCTION: Fixation of mesh during minimally invasive inguinal hernia repair is thought to contribute to chronic post-herniorrhaphy groin pain (CGP). In contrast to permanent tacks, absorbable tacks are hypothesized to minimize the likelihood of CGP. This study aimed to compare the rates of CGP after laparoscopic inguinal hernia repair between absorbable versus permanent fixation at maximum follow-up. METHODS: This is a post hoc analysis of a randomized controlled trial in patients undergoing laparoscopic inguinal hernia repair (NCT03835351). All patients were contacted at maximum follow-up after surgery to administer EuraHS quality of life (QoL) surveys. The pain and restriction of activity subdomains of the survey were utilized. The primary outcome was rate of CGP, as defined by a EuraHS QoL pain domain score ≥ 4 measured at ≥ 1 year postoperatively. The secondary outcomes were pain and restriction of activity domain scores and hernia recurrence at maximum follow-up. RESULTS: A total of 338 patients were contacted at a mean follow-up of 28 ± 11 months. 181 patients received permanent tacks and 157 patients received absorbable tacks during their repair. At maximum follow-up, the rates of CGP (27 [15%] vs 28 [18%], P = 0.47), average pain scores (1.78 ± 4.38 vs 2.32 ± 5.40, P = 0.22), restriction of activity scores (1.39 ± 4.32 vs 2.48 ± 7.45, P = 0.18), and the number of patients who reported an inguinal bulge (18 [9.9%] vs 15 [9.5%], P = 0.9) were similar between patients with permanent versus absorbable tacks. On multivariable analysis, there was no significant difference in the odds of CGP between the two groups (OR 1.23, 95% CI [0.60, 2.50]). CONCLUSION: Mesh fixation with permanent tacks does not appear to increase the risk of CGP after laparoscopic inguinal hernia repair when compared to fixation with absorbable tacks. Prospective trials are needed to further evaluate this relationship.

Long-term Clinical and Patient-Reported Outcomes After Transversus Abdominis Release With Permanent Synthetic Mesh: A Single Center Analysis of 1203 Patients.

OBJECTIVE: We aimed to report long-term clinical and patient-reported outcomes of transversus abdominis release (TAR) with permanent synthetic mesh performed in a high-volume abdominal wall reconstruction practice. SUMMARY BACKGROUND DATA: Despite increasing utilization of TAR in abdominal wall reconstruction, long-term clinical and patient-reported outcomes remain uncertain. METHODS: Prospectively collected registry data from the Cleveland Clinic Center for Abdominal Core Health were analyzed retrospectively. Patients undergoing elective, open VHR with TAR and permanent synthetic mesh implantation between August 2014 and March 2020 with 30-day clinical and ≥1 year clinical or patient-reported outcome follow-up were included. Outcomes included composite hernia recurrence, characterized by patient-reported bulges and recurrent hernias noted on physical exam or imaging, as well as hernia-specific quality of life and pain. RESULTS: A total of 1203 patients were included. Median age was 60 years [interquartile range (IQR): 52-67], median body mass index was 32 kg/m 2 (IQR: 28-36), median hernia width was 15 cm (IQR: 12-19), and 57% of hernias were recurrent. Fascial reapproximation was achieved in 92%. At a median follow-up of 2 years (IQR: 1-4), the overall composite hernia recurrence rate was 26%, with sensitivity analysis yielding best-case and worst-case estimates of 5% and 28%, respectively. Patients experienced improved hernia-specific quality of life and pain regardless of recurrence outcome; however, those who did not recur experienced more substantial improvement. CONCLUSIONS: TAR with permanent synthetic mesh remains a valuable, versatile technique; however, surgeon and patient expectations should be tempered regarding long-term durability. Despite a high rate of recurrence, patients experience measurable improvements in quality of life.

Surgical approaches for core abdominal injuries: a review of the Abdominal Core Health Quality Collaborative database.

INTRODUCTION: Core abdominal injury (CAI) is a broad term that describes injuries resulting from repetitive loading of the pubis that leads to inflammation, rupture, or destabilization of the core muscles from the pubic bone. There is no clear recommendation on the surgical approach to CAI. We aimed to describe how hernia surgeons within the Abdominal Core Health Quality Collaborative (ACHQC) address this problem surgically and the short-term outcomes. METHODS: We queried the ACHQC registry for patients undergoing surgery for isolated CAI and concomitant inguinal hernias (IH) and CAI. Operative approach and quality of life (using EuraHS survey scores) was abstracted. RESULTS: A total of 29,451 patients underwent surgery for IHs, CAIs, or both within the registry. Twenty patients underwent surgery for isolated CAI (median age 29, 90% males). Eleven patients (55%) underwent surgery with mesh (four Lichtenstein, three TAPP, and four TEP). Nine patients (45%) underwent tissue-based repairs (four closure of floor, one Bassini, one McVay, one Shouldice, one femoral exploration, and one laparoscopic-to-open conversion). There were no postoperative complications or reoperations within 30 days. EuraHS scores showed improvement at 30 days from baseline (median 29 [6.75-41.75] from 42 [29.42-57.61]). Sixty patients had both IHs and CAIs (median age 31, 97% males). All patients received mesh. Thirty-one patients (52%) underwent open surgery (23 Lichtenstein, 1 plug, 7 TREPP) and 29 underwent minimally invasive repairs (23 TAPP, 6 TEP). There was one seroma at 30 days. EuraHS scores showed improvement at 30 days from baseline (median 16 [5.17-27.33] from 37.5 [26.44-46.58]). CONCLUSIONS: Despite technical variability, CAIs with or without concomitant IH generally undergo operations commonly used for IH repairs. Within our series, there was inconsistency with approach and mesh placement. Future work should be focused on standardizing the approach to CAI and capturing long-term data within the ACHQC.

Injuries incurred from minimally invasive access for abdominal surgery.

BACKGROUND: Injuries during initial port placement in minimally invasive abdominal surgery are rare but can cause major morbidity. We aimed to characterize the incidence, consequence, and risk factors for injury occurring on initial port placement. METHODS: This is a retrospective review of a General Surgery quality collaborative database with supplementary input from the Morbidity and Mortality conference database at our institution between 6/25/2018 and 6/30/2022. Patient characteristics, operative details, and postoperative course were assessed. Cases with an injury on entry were compared to cases without an injury to identify risk factors for injury. RESULTS: 8844 minimally invasive cases were present between the two databases. Thirty-four injuries (0.38%) occurred during initial port placement. Seventy-one percent of injuries were bowel injuries (full or partial thickness) and the majority (79%) of injuries were recognized during the index operation. Median surgeon experience for the cases with an injury was 9 years (IQR 4.25-14.5) compared to 12 years of experience for all surgeons contributing to the database (p = 0.004). Previous laparotomy was also significantly correlated with the rate of injury on entry (p = 0.012). There was no significant difference in the rate of injury based on method of entry (cut-down: 19 (55.9%), optical entry without Veress: 10 (29.4%), Veress followed by optical entry: 5 (14.7%), p = 0.11). BMI > 30 kg/m2 (injury: 16/34 vs no injury: 2538/8844, p = 0.847) was not associated with an injury. Fifty-six percent (19/34) of patients with an injury on initial port placement required laparotomy at some point in their hospital course. CONCLUSIONS: Injuries are rare during initial port placement for minimally invasive abdominal surgery. In our database, history of a previous laparotomy was a significant risk factor for an injury and appears to be more consequential than commonly implicated factors such as technique, patient body habitus, or surgeon experience.

Single-staged retromuscular abdominal wall reconstruction with mesh at the time of ostomy reversal: are we crossing the line? An ACHQC Analysis.

INTRODUCTION: The most appropriate method of reconstructing the abdominal wall at the site of a simultaneous stoma takedown is controversial. The contaminated field, concomitant GI procedure being performed and presence of a hernia all complicate decision-making. We sought to describe the surgical approaches, mesh type and outcomes of concomitant abdominal wall reconstruction during stoma takedown in a large hernia registry. METHODS AND PROCEDURES: All patients who underwent stoma takedown with simultaneous hernia repair with retromuscular mesh placement from January 2014 to May 2022 were identified within the Abdominal Core Health Quality Collaborative (ACHQC). Patients were stratified by mesh type including permanent synthetic (PS), resorbable synthetic (RS) and biologic mesh. Association of mesh type with 30-day wound events and other complications and 1-year outcomes were evaluated. RESULTS: There were 368 patients who met inclusion criteria. Eighty-nine patients had ileostomies, 276 colostomies and 3 had both. Two hundred and seventy-nine (75.8%) patients received PS mesh, 46 (12.5%) biologic, and 43 (11.7%) RS. Seventy percent (259/368) had a parastomal hernia, 75% (285/368) had a midline incisional hernia, and 48% (178/368) had both. All groups had similar preoperative comorbidities and the majority had a transversus abdominus release. All mesh groups had similar thirty-day SSI (13.2-14.3%), SSO (10.5-17.8%) and SSOPI (7.9-14.1%), p = 0.6. Three patients with PS mesh developed infected synthetic mesh and one PS mesh required excision. Four patients with PS developed an enterocutaneous fistula. Of these, only one patient was recorded as having both an enterocutaneous fistula and mesh infection. Thirty-day reoperation and readmission were similar across all mesh groups. Recurrence at 1-year was similar between mesh groups. Quality of life measured using HerQLes scores were higher at one year compared to baseline in all groups indicating improvement in hernia-specific quality of life. CONCLUSION: Early complication rates associated with simultaneous stoma takedown and abdominal wall reconstruction are significant, regardless of mesh type utilized. Concomitant surgery should be weighed heavily and tailored to individual patients.

Mediumweight polypropylene mesh fractures after open retromuscular ventral hernia repair: incidence and associated risk factors.

PURPOSE: Mediumweight (MW) and heavyweight (HW) polypropylene have demonstrated similar clinical and patient-reported outcomes in the setting of open retromuscular ventral hernia repair (VHR). While MW mesh has an anecdotal risk of central mesh fracture, that phenomenon is not well-characterized. We sought to assess the incidence of and risk factors for MW polypropylene mesh fractures after VHR. METHODS: The ACHQC registry was queried for patients with CT-documented hernia recurrence after open retromuscular VHR with MW polypropylene mesh at our institution with 1-year follow-up between January 2014 and April 2022. Images were reviewed by five blinded surgeons at Cleveland Clinic to reach consensus that hernia recurrence mechanism was central mesh fracture. Patients without clinical recurrence or patient-reported bulge were used as a comparator group. RESULTS: Eighty patients were identified with radiographically documented recurrence; 28 had recurrence from mesh fractures and these were compared to 644 patients without recurrence. Incidence of MW fracture was 4.2%. Bridging of anterior fascia was more common in the group with the central mesh fracture (33.3% vs 3.3%, p < 0.001); the incidence of fracture was 30% (9/30) in patients requiring a bridged closure. Mesh fracture was associated with larger hernias (median width: 20 cm [16-26] vs 15 cm [12-18], p < 0.001,), length (25 cm [23-30] vs 23 cm [19-26], p = 0.004). CONCLUSION: MW polypropylene mechanical failures are surprisingly common, particularly in settings of bridged fascial closure and larger hernias. Use of HW polypropylene should be considered in this setting, and industry should be encouraged to create larger pieces of HW polypropylene mesh.

Laparoscopic versus robotic inguinal hernia repair: 1- and 2-year outcomes from the RIVAL trial.

INTRODUCTION: Robotic inguinal hernia repair is growing in popularity among general surgeons despite little high-quality evidence supporting short- or long-term advantages over traditional laparoscopic inguinal hernia repair. The original RIVAL trial showed increased operative time, cost, and surgeon frustration for the robotic approach without advantages over laparoscopy. Here we report the 1- and 2-year outcomes of the trial. METHODS: This is a multi-center, patient-blinded, randomized clinical study conducted at six sites from 2016 to 2019, comparing laparoscopic versus robotic transabdominal preperitoneal (TAPP) inguinal hernia repair with follow-up at 1 and 2 years. Outcomes include pain (visual analog scale), neuropathic pain (Leeds assessment of neuropathic symptoms and signs pain scale), wound morbidity, composite hernia recurrence (patient-reported and clinical exam), health-related quality of life (36-item short-form health survey), and physical activity (physical activity assessment tool). RESULTS: Early trial participation included 102 patients; 83 (81%) completed 1-year follow-up (45 laparoscopic vs. 38 robotic) and 77 (75%) completed 2-year follow-up (43 laparoscopic vs. 34 robotic). At 1 and 2 years, pain was similar for both groups. No patients in either treatment arm experienced neuropathic pain. Health-related quality of life and physical activity were similar for both groups at 1 and 2 years. No long-term wound morbidity was seen for either repair type. At 2 years, there was no difference in hernia recurrence (1 laparoscopic vs. 1 robotic; P = 1.0). CONCLUSIONS: Laparoscopic and robotic inguinal hernia repairs have similar long-term outcomes when performed by surgeons with experience in minimally invasive inguinal hernia repairs.

Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial.

BACKGROUND: For small to medium-sized ventral hernias, robotic intraperitoneal onlay mesh (rIPOM) and enhanced-view totally extraperitoneal (eTEP) repair have emerged as acceptable approaches that each takes advantage of robotic instrumentation. We hypothesized that avoiding mesh fixation in a robotic eTEP repair offers an advantage in early postoperative pain compared to rIPOM. METHODS: This is a multi-center, randomized clinical trial for patients with midline ventral hernias ≤ 7 cm, who were randomized to rIPOM or robotic eTEP. The primary outcome was pain (0-10) on the first postoperative day. Secondary outcomes included same-day discharge, length of stay, opioid consumption, quality of life, surgeon workload, and cost. RESULTS: Between November 2019 and November 2021, 100 patients were randomized (49 rIPOM, 51 eTEP) among 5 surgeons. Pain on the first postoperative day [median (IQR): 5 (4-6) vs. 5 (3.5-7), p = 0.66] was similar for rIPOM and eTEP, respectively, a difference maintained following adjustments for surgeon, operative time, baseline pain, and patient co-morbidities (difference 0.28, 95% CI - 0.63 to 1.19, p = 0.56). No differences in pain on the day of surgery, 7, and 30 days after surgery were identified. Same-day discharge, length of stay, opioid consumption, and 30-day quality of life were also comparable, though rIPOM required less surgeon workload (p < 0.001), shorter operative time [107 (86-139) vs. 165 (129-212) min, p < 0.001], and resulted in fewer surgical site occurrences (0 vs. 8, p = 0.004). The total direct costs for rIPOM and eTEP were comparable [$8282 (6979-11835) vs. $8680 (7550-10282), p = 0.52] as the cost savings for eTEP attributable to mesh use [$442 (434-485) vs. $69 (62-76), p = < 0.0001] were offset by increased expenses for operative time [$669 (579-861) vs. $1075 (787-1367), p < 0.0001] and use of more robotic equipment [$760 (615-933) vs. $946 (798-1203), p = 0.001]. CONCLUSION: The avoidance of fixation in a robotic eTEP repair did not reveal a benefit in postoperative pain to offset the shorter operative time and surgeon workload offered by rIPOM.

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.

Clinical and surgical outcomes of splenectomy for autoimmune hemolytic anemia.

INTRODUCTION: We investigated short and long-term remission rates after splenectomy in patients with primary and secondary autoimmune hemolytic anemia (AIHA). METHODS: All adults who underwent splenectomy for primary or secondary AIHA at a single center (2004-2018) were retrospectively reviewed. Short-term response was determined at 30-day postoperatively and long-term at one year. Complete response was defined as hemoglobin > 10 g/dL without hemolysis, transfusions, or need for additional medical therapy for > 6 months. RESULTS: Short-term complete response was attained in 22 of 36 patients (61%), partial response in 3 (8%), no response in 11 (31%). The response rate at 1 year was complete in 14/36 (39%), partial in 14 (39%), and 8 non-response (22%). At last available follow-up (median 33.1 months (IQR 19-59), 16/37 patients had experienced a complete response (43%), 14 partial response (38%), 7 non-response (19%). 80% of partial responders with primary AIHA required maintenance therapy compared to 100% with secondary AIHA. CONCLUSION: Splenectomy is associated with short- and long-term improvement in anemia and hemolysis in the majority of patients with AIHA. Immunosuppressants remain important supplemental therapy.

Registry-Based Trainee Assessments: Leveraging a Quality Collaborative for Surgical Education.

INTRODUCTION: We present our experience developing and embedding a registry-based module for resident feedback. METHODS: At our institution, entering operative data into the institutional quality collaborative registry is standard practice. In February 2019, a surgical education module was embedded into the registry to capture procedure-specific resident operative assessments. Faculty engagement with the sugical education module was assessed during its first year in existence (February 2019-February 2020). RESULTS: In total, 1074 of 1269 (85%) operative assessments were completed by 27 faculty via the surgical education registry module. Median faculty engagement rate with the module following resident-assisted procedures was 91% [IQR 76%-100%]. Residents received a median of 7 operative assessments [IQR 2-19] over the study period. CONCLUSION: By embedding a surgical education module into an existing surgical quality collaborative registry, procedure-specific operative assessments can be routinely captured.

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.

The Diagnostic Utility of Splenectomy in Idiopathic Splenomegaly.

INTRODUCTION: With increasing frequency, patients with idiopathic splenomegaly are referred to surgeons for splenectomy. We evaluated the diagnostic utility of splenectomy and feasibility of a minimally invasive approach in the face of idiopathic splenomegaly. METHODS: We retrospectively reviewed 68 patients who underwent splenectomy for idiopathic splenomegaly. The primary endpoint was the rate of definitive diagnosis based on final surgical pathology of the removed spleen. RESULTS: Preoperative workup included a bone marrow biopsy and peripheral blood smear in 93% and 100% of patients, respectively, with none having lymphadenopathy warranting biopsy. Splenectomy provided a definitive diagnosis for 44 (64.7%) patients. Of these, 34 (50%) patients had an underlying malignancy, of which more than half were splenic marginal zone lymphoma. There were 33 (48.5%) laparoscopic, 23 (33.8%) open, 10 (14.7%) laparoscopic converted to open, and two (2.9%) laparoscopic hand-assist cases. Conversion to open was due to splenic size [median craniocaudal length 21.8 cm (cm)] in eight and staple line bleeding at the splenic hilum in two patients. Overall, the laparoscopic approach was completed in patients with a smaller splenic size compared to open (median craniocaudal length 15.2 vs. 26.0 cm, p < 0.0001). The open group had one (1.5%) intra-operative mortality due to uncontrollable hemorrhage. Thirty-day complication rates were similar for laparoscopic and open approaches (p = 0.10). CONCLUSION: Splenectomy is an effective diagnostic modality in determining a pathologic cause for splenomegaly in this patient population. Laparoscopic splenectomy can be performed safely in appropriate cases with craniocaudal splenic size having the largest influence on surgical approach.

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.

Development of a Disease-based Hernia Program and the Impact on Cost for a Hospital System.

OBJECTIVE: The aim of this study was to assess the impact of developing a hernia program on mesh utilization. BACKGROUND: With the ongoing changes in healthcare, the value of all interventions will see increased scrutiny. Hernia mesh can be one of the most costly components of hernia repairs. A disease-based institutional hernia program that defines roles for mesh utilization and measures outcomes has the potential to add significant value to hospital systems. METHODS: In August 2014, a disease-based hernia program was initiated across a hospital system. In collaboration with hospital administration, surgical operations, and all surgeons involved in the care of hernia patients, general guidelines for mesh utilization based on CDC wound class were created. All hernia repairs performed between January 2013 and November 2015 were reviewed. RESULTS: Approximately, 13,937 hernias were repaired during the study period. Biologic mesh was used in 0.4% of clean, 7.1% of clean-contaminated, 38.5% of contaminated, and 58.8% of dirty cases. After initiation of the hernia program there was a reduction in biologic mesh utilization across the system (clean: 66% reduction; clean-contaminated: 63% reduction; contaminated: 55% reduction; dirty: 47% reduction). Surgeons who participated in the hernia program used significantly less biologic mesh in clean (P < 0.01), clean-contaminated (P = 0.01) and contaminated (P < 0.01) hernia repairs. CONCLUSIONS: The development of a system-wide hernia program based on collaboration with the hospital administration, operating room purchasing and clinicians resulted in a significant reduction in costly mesh utilization. This collaborative effort from all stakeholders involved in the care of a specific disease process could provide a reproducible model to improve the value equation through cost reduction strategies in today's healthcare environment.

Is It Time to Reconsider Postoperative Epidural Analgesia in Patients Undergoing Elective Ventral Hernia Repair?: An AHSQC Analysis.

OBJECTIVE: We aimed to evaluate the association of epidural analgesia (EA) with hospital length of stay (LOS), wound morbidity, postoperative complications, and patient-reported outcomes in patients undergoing ventral hernia repair (VHR). BACKGROUND: EA has been shown to reduce LOS in certain surgical populations. The LOS benefit in VHR is unclear. METHODS: Patients having VHR performed in the Americas Hernia Society Quality Collaborative (AHSQC) were separated into 2 comparable groups matched on several confounding factors using a propensity score algorithm: one group received postoperative EA, and the other did not. The groups were then evaluated for hospital LOS, 30-day wound morbidity, other complications, and 30-day patient-reported outcomes using pain and hernia-specific quality-of-life instruments. RESULTS: A 1:1 match was achieved and the final analysis included 763 patients receiving EA and 763 not receiving EA. The EA group had an increased LOS (5.49 vs 4.90 days; P < 0.05). The rate of wound events was similar between the groups. There was an increased risk of having any postoperative complication associated with having EA (26% vs 21%; P < 0.05). Pain intensity-scaled scores were significantly higher (worse) in the EA group versus the non-EA group (47.6 vs 44.0; P = 0.04). CONCLUSIONS: The LOS benefit of EA noted for other operations may not apply to patients undergoing VHR. Further study is necessary to determine the beneficial role of invasive pain management procedures in this group of patients with an extremely common disease state.

Development of a critical-sized ventral hernia model in the pig.

BACKGROUND: The pig is commonly used as a preclinical model for ventral hernia repair. However, no study has verified that an unrepaired surgically induced hernia (control) in the pig does not heal spontaneously but rather develops a persistent hernia. Without such verification in any given model, one cannot draw conclusions on the efficacy of the repair technique investigated. MATERIALS AND METHODS: Three surgically induced hernia models with increasing severity were created in eight pigs. These included 10-cm retrorectus partial-thickness (model 1) and 15-cm preperitoneal full-thickness (model 2) incisional defects and an 8 × 8 cm preperitoneal full-thickness excisional defect (model 3). Postoperative management included use of an abdominal binder, and in some cases, suction drainage, for 2 wk to support the repair and prevent seroma. Models were evaluated for persistence of hernia at 5 wk using clinical and radiographic assessments. RESULTS: All pigs developed clinical hernias after 2 wk of defect creation, but only models 1 and 3 had clinically persistent hernias at 5 wk. At 5 wk, the average defect area was 97 cm2 in model 1, 66 cm2 in model 2, and 245 cm2 in model 3. Dense fibrotic scarring was observed in the models with resolved hernias. CONCLUSIONS: Our results highlight the need to verify an unrepaired hernia injury model does not heal spontaneously prior to using it for hernia repair studies. The partial-thickness incisional model 1 and full-thickness excisional model 3 formed persistent hernias in pigs at 5 wk and should be further explored as models for investigating hernia repair strategies.

Infection prevention using affinity polymer-coated, synthetic meshes in a pig hernia model.

BACKGROUND: Given concern for hernia mesh infection, surgeons often use biologic mesh which may provide reduced risk of infection but at the cost of decreased repair durability. We evaluated mesh coating to provide sustained release of antibiotics to prevent prosthetic mesh infection and also allow a durable repair. MATERIALS AND METHODS: Cyclodextrin-based polymer was crosslinked onto multifilament polyester mesh and loaded with vancomycin (1.75 mg/cm2). Pigs received modified meshes (n = 6) or normal, untreated meshes (n = 4), which were implanted into acute 10 × 5 cm ventral hernia, then directly inoculated with 106 colony-forming unit (CFU) of methicillin-resistant Staphylococcus aureus (MRSA). These were compared to animals receiving normal, uninfected mesh. All mesh was secured in an underlay bridge manner, and after 30 d, the abdominal wall was removed for quantitative bacterial culture and biomechanical analysis. RESULTS: All animals survived 30 d. All six animals with coated mesh cleared MRSA infection. The four control animals did not clear MRSA (P = 0.005). Quantitative bacterial load was higher in standard mesh versus drug-delivery mesh group (2.34 × 104versus 80.9 CFU/gm). These data were log10-transformed and analyzed by Welch's t-test (P = 0.001). Minimum number of CFUs detectable by assay (300) was used instead of zero. Biomechanical analysis of controls (1.82 N/mm infected; 1.71 N/mm uninfected) showed no difference to the modified meshes (1.31 N/mm) in tissue integration (P = 0.15). CONCLUSIONS: We successfully prevented synthetic mesh infection in a pig model using a cyclodextrin-based polymer to locally deliver vancomycin to the hernia repair site and clearing antibiotic-resistant bacteria. Polymer coating did not impact the strength of the hernia repair.

Effects of mesenchymal stem cell and fibroblast coating on immunogenic potential of prosthetic meshes in vitro.

BACKGROUND: The aim of this study was to reveal the effect of fibroblast or mesenchymal stem cell (MSC) coating on the mesh-induced production of IL-1ß, IL-6, and VEGF by macrophages. METHODS: Four commonly used surgical meshes were tested in this study, including Parietex, SoftMesh, TIGR, and Strattice. One-square-centimeter pieces of each mesh were placed on top of a monolayer of human fibroblasts or rat MSCs. The coating status was monitored with a light microscope. The human promonocytic cell line U937 was induced to differentiate into macrophages (MΦ). Three weeks later, meshes were transferred to new 24-well plates and cocultured with the MΦs for 72 h. Culture medium was collected and analyzed for IL-1ß, IL-6, and VEGF production using standard ELISA essays. Parallel mesh samples were fixed with paraformaldehyde or glutaraldehyde for histology or transmission electronic microscopy (TEM) analyses, respectively. RESULTS: Uncoated meshes induced increased production of all three cytokines compared with macrophages cultured alone. HF coating further increased the production of both IL-6 and VEGF but reduced IL-1ß production. Except for the SoftMesh group, MSC coating significantly blunted release of all cytokines to levels even lower than with MΦs cultured alone. MΦs tended to deteriorate in the presence of MSCs. Both histology and TEM revealed intimate interactions between cell-coated meshes and MΦs. CONCLUSIONS: Cytokine response to fibroblast coating varied, while MSC coating blunted the immunogenic effect of both synthetic and biologic meshes in vitro. Cell coating appears to affect mesh biocompatibility and may become a key process in mesh evolution.