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.

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.

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.

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.

Tipping the scale in abdominal wall reconstruction: An analysis of short- and long-term outcomes by body mass index.

BACKGROUND: Morbid obesity, with a body mass index 35 kg/m2, is a commonly used cutoff for denying elective transversus abdominis release. Although obesity is linked to short-term wound morbidity, its effect on long-term outcomes remains unknown, calling into question if a cutoff is justified. We sought to compare 1-year recurrence rates after transversus abdominis release based on body mass index and to evaluate short- and long-term outcomes. METHODS: Patients undergoing open, clean transversus abdominis release from August 2014 to January 2022 at our institution with 1-year follow-up completed were identified. Univariate and multivariable analyses were performed to determine the association of body mass index with 90-day wound events, 1-year hernia recurrence, and hernia-specific quality of life. Covariates included body mass index, diabetes, recurrent hernia, hernia width, fascial closure, surgical site occurrence requiring procedural intervention, previous abdominal wall surgical site infection, inflammatory bowel disease, mesh weight, and mesh-to-hernia size ratio. RESULTS: A total of 1,089 patients were included. Increasing body mass index was associated with surgical site infection (adjusted odds ratio = 1.59; 95% confidence interval, 1.14-1.77; P < .01) and surgical site occurrence (adjusted odds ratio = 1.42; 95% confidence interval, 1.13-1.74; P < .01) but was not associated with surgical site occurrence requiring procedural intervention. Hernia width was associated with surgical site occurrence (adjusted odds ratio = 1.4; 95% confidence interval, 1.08-1.82; P < .01) and surgical site occurrence requiring procedural intervention (adjusted odds ratio = 1.4; 95% confidence interval, 1.08-1.82; P = .01). Hernia recurrence rate at 1 year was lower for the body mass index ≥35 kg/m2 group (7% vs 12%; P = .02). Hernia width (odds ratio = 1.33; 95% confidence interval, 1.02-1.74; P = .04) was associated with recurrence; body mass index was not (P = .11). Both groups experienced significant improvement in hernia-specific quality of life at 1 year. CONCLUSION: Morbid obesity is associated with 90-day wound morbidity; however, short-term complications did not translate to higher reoperation or long-term recurrence rates. The impact of body mass index on hernia recurrence is likely overstated. An arbitrary body mass index cutoff of 35 kg/m2 should not be used to deny symptomatic patients abdominal wall reconstruction.

Evaluating the impact of lifting mandatory smoking cessation prior to elective abdominal wall reconstruction. A single-center experience.

INTRODUCTION: Many studies identify active smoking as a significant risk factor for postoperative wound and mesh complications in patients undergoing abdominal wall reconstruction surgery. However, our group conducted an analysis using data from the ACHQC database, which revealed similar rates of surgical site infection (SSI) and surgical site occurrence requiring procedural intervention (SSOPI) between active smokers and non-smokers As a result, the Cl eveland Clinic Center for Abdominal Core Health instituted a policy change where active smokers were no longer subject to surgical delay. Our study aims to evaluate the impact of active smoking on the outcomes of these patients. METHODS: We identified active smoking patients who had undergone open, elective, clean ventral hernia repair (VHR) with transversus abdominis release (TAR) and permanent synthetic mesh at Cleveland Clinic Foundation. Propensity matching was performed to create a 1:3 ratio of "current-smokers" and "never-smokers" and compared wound complications and all 30-day morbidity between the two groups. RESULTS: 106 current-smokers and 304 never-smokers were matched. Demographics were similar between the two groups after matching, with the exception of chronic obstructive pulmonary disease (COPD) (22.1% vs. 13.4%, p â€‹< â€‹.001) and body mass index (BMI) (31.1 vs. 32.6, p â€‹= â€‹.02). Rates of SSI (12.2% vs. 6.9%, p â€‹= â€‹.13), SSO (21.7% vs. 13.2%, p â€‹= â€‹.052), SSOPI (11.3% vs. 6.3%, p â€‹= â€‹.13), and reoperation (1.9% vs. 3.9%, p â€‹= â€‹.53) were not significantly different between active smokers and never-smokers correspondingly. One case (0.3%) of partial mesh excision was observed in the never-smokers group (p â€‹= â€‹1). The current-smokers group exhibited a significantly higher incidence of pneumonia compared to the never-smokers group (5.7% vs. 0.7%, p â€‹= â€‹.005). CONCLUSION: Our study revealed that operating on active smokers did result in a slight increase in wound morbidity, although it did not reach statistical significance. Additionally, pulmonary complications were higher in the smoking group. Notably, we did not see any mesh infections in the smoking group during early follow up. We believe that this data is important for shared decision making on patients that are actively smoking contemplating elective hernia repair.

Mesh versus suture repair of incisional hernias 2 cm or less: Is mesh necessary? A propensity score-matched analysis of the abdominal core health quality collaborative.

BACKGROUND: Mesh has been the acceptable standard for incisional hernia repair regardless of hernia size. It is not clear whether there is a size of incisional hernias in whom repair would be best performed without mesh. This study aims to compare outcomes of mesh versus suture repairs for incisional hernias <2 cm in size. METHODS: Incisional hernia repairs from 2012 to 2021 for hernias ≤2 cm in width were queried from the Abdominal Core Health Quality Collaborative. Those with 1-year follow up were considered. Hernia recurrence was defined using composite hernia recurrence, which combines both clinical and patient reported outcomes. Propensity score matching was performed between mesh and non-mesh using body mass index, smoking, diabetes, and drains as covariates. RESULTS: A total of 352 patients met inclusion criteria. After propensity score matching, there were 132 repairs with mesh and 71 without. There was no difference in recurrence rates at 1 year between mesh and non-mesh repairs (15% vs 24%, P = .12). Mesh was associated with a higher rate of 30-day postoperative complications (11% vs 1%, P = .017). There were no differences in 1-year quality of life scores. CONCLUSION: The repair of incisional hernias ≤2 cm without mesh results in similar recurrence rates, similar quality of life scores, and lower postoperative early complications compared with repairs with mesh. Our findings suggest that there may be select patients with small incisional hernias that could reasonably undergo incisional hernia repair without mesh. Longer-term follow-up is needed to confirm ideal candidates and durability of these repairs.

Open Retromuscular Sugarbaker vs Keyhole Mesh Placement for Parastomal Hernia Repair: A Randomized Clinical Trial.

Importance: Durable parastomal hernia repair remains elusive. There is limited evidence comparing the durability of the open retromuscular Sugarbaker and keyhole mesh configurations. Objective: To determine if the open retromuscular Sugarbaker mesh placement technique would lower parastomal hernia recurrence rates. Design, Setting, and Participants: In this single-center, randomized clinical trial, 150 patients with a permanent stoma and associated parastomal hernia who were candidates for open retromuscular parastomal hernia repair were enrolled and randomized from April 2019 to April 2022 and followed up for 2 years. Interventions: Following intraoperative assessment to determine the feasibility of either technique, enrolled patients were randomized to receive either retromuscular Sugarbaker or keyhole synthetic mesh placement. Main Outcomes and Measures: The primary outcome was parastomal hernia recurrence at 2 years. Secondary outcomes included mesh-related complications, wound complications, reoperations, as well as patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at 1 year and 2 years. Results: A total of 150 patients were randomized, and with 91% follow-up at 2 years, there were 13 (17%) parastomal hernia recurrences in the retromuscular Sugarbaker arm and 18 (24%) in the keyhole arm (adjusted risk difference, -0.029; 95% CI, -0.17 to 0.153, and adjusted risk ratio, 0.87; 95% CI, 0.42 to 1.69). There were no statistically significant differences between the Sugarbaker and keyhole groups regarding reoperations for recurrence (2 vs 7, respectively), nonhernia intra-abdominal pathology (4 vs 10, respectively), stoma necrosis (1 vs 0, respectively), mesh-related complications (4 vs 1, respectively), patient-reported pain, abdominal wall-specific quality of life, stoma-specific quality of life, and decision regret at any time point. Conclusions and Relevance: In the setting of open parastomal hernia repair, a retromuscular Sugarbaker mesh placement technique was not superior to a keyhole configuration 2 years after repair. Further innovation is necessary to improve parastomal hernia repair outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03972553.

Abdominal Wall Tension and Early Outcomes after Posterior Component Separation with Transversus Abdominis Release: Does a "Tension-Free" Closure Really Matter?

BACKGROUND: Ventral hernias result in fibrosis of the lateral abdominal wall muscles, increasing tension on fascial closure. Little is known about the effect of abdominal wall tension on outcomes after abdominal wall reconstruction. We aimed to identify an association between abdominal wall tension and early postoperative outcomes in patients who underwent posterior component separation (PCS) with transversus abdominis release (TAR). STUDY DESIGN: Using a proprietary, sterilizable tensiometer, the tension needed to bring the anterior fascial elements to the midline of the abdominal wall during PCS with TAR was recorded. Tensiometer measurements, in pounds (lb), were calibrated by accounting for the acceleration of Earth's gravity. Baseline fascial tension, change in fascial tension, and fascial tension at closure were evaluated with respect to 30-day outcomes, including wound morbidity, hospital readmission, reoperation, ileus, bleeding, and pulmonary complications. RESULTS: A total of 100 patients underwent bilateral abdominal wall tensiometry, for a total of 200 measurements (left and right side for each patient). Mean baseline anterior fascial tension was 6.78 lb (SD 4.55) on each side. At abdominal closure, the mean anterior fascial tension was 3.12 (SD 3.21) lb on each side. Baseline fascial tension and fascial tension after PCS with TAR at abdominal closure were not associated with surgical site infection, surgical site occurrence, readmission, ileus, and bleeding requiring transfusion. The event rates for all other complications were too infrequent for statistical analysis. CONCLUSIONS: Baseline and residual fascial tension of the anterior abdominal wall do not correlate with early postoperative morbidity in patients undergoing PCS with TAR. Further work is needed to determine if abdominal wall tension in this context is associated with long-term outcomes, such as hernia recurrence.

Postoperative bleeding after complex abdominal wall reconstruction: A post hoc analysis of a randomized clinical trial.

BACKGROUND: Abdominal wall reconstruction requires extensive dissection of the abdominal wall, exposure of the retroperitoneum, and aggressive chemoprophylaxis to reduce the risk of thromboembolic complications. The need for early anticoagulation puts patients at risk for bleeding. We aimed to quantify postoperative blood loss, incidence of transfusion and reoperation, and associated risk factors in patients undergoing complex abdominal wall reconstruction. METHODS: All patients underwent a posterior component separation with transversus abdominis release and placement of retromuscular mesh for ventral hernias <20 cm wide and were enrolled in a clinical trial assessing the utility of trans-fascial mesh fixation. A post hoc analysis was performed to quantify postoperative hemoglobin drop, blood transfusions, and procedural interventions for ongoing bleeding during the first 30 postoperative days. Multivariate logistic regression was used to identify predictors of transfusion. RESULTS: In 325 patients, hemoglobin decreased by 3.61 (±1.58) g/dL postoperatively. Transfusion incidence was 9.5% (n = 31), and 3.1% (n = 10) required a surgical intervention for bleeding. Initiation of therapeutic anticoagulation postoperatively resulted in a higher likelihood of requiring surgical intervention for bleeding (odds ratio 10.4 [95% confidence interval 2.75-43.8], P < .01). Use of perioperative therapeutic anticoagulation was associated with higher rates of transfusion (odds ratio 3.51 [95% confidence interval 1.34-8.53], P < .01). Neither intraoperative blood loss nor operative times were associated with an increased transfusion requirement or need for operative intervention. CONCLUSION: Patients undergoing transversus abdominis release are at a high risk of postoperative bleeding that can require transfusion and reoperation. Patients requiring postoperative therapeutic anticoagulation are at particularly high risk.

The impact of diabetes and presurgical glycemic control on wound morbidity following open complex abdominal wall reconstruction: a single-center experience.

INTRODUCTION: Numerous studies have identified diabetes mellites (DM) as a significant risk factor for postoperative wound morbidity, with suboptimal preoperative glycemic control (GC) posing an even greater risk. However, this data largely excludes ventral hernia patients. Our study examined the association between diabetes and preoperative GC and postoperative outcomes following open complex abdominal wall reconstruction (AWR). METHODS: We identified diabetic patients who had undergone open, elective, clean VHR with transversus abdominis release (TAR) and permanent synthetic mesh at the Cleveland Clinic Foundation between January 2014 and December 2023. Their 30-day outcomes were compared to non-diabetic patients undergoing the same procedure. Subsequently, diabetic patients were categorized based on GC. status: "Optimal GC" (HbA1c < 7%), "Sub-optimal GC" (HbA1c 7-8.4%), and "Poor GC" (HbA1c ≥ 8.5%) and their outcomes were compared. RESULTS: 514 patients with DM who underwent clean elective TAR were identified, of which 431 met the inclusion criteria. GC was deemed optimal in 255 patients, sub-optimal in 128, and poor in 48 patients. Demographics were similar, except for anticoagulation treatment (p = 0.014). The entire study population exhibited significantly higher rates of wound morbidities and overall complications compared to non-diabetic patients. However, rates of surgical site infection (SSI), surgical site occurrence (SSO), SSO requiring procedural intervention (SSOPI), and reoperation did not differ significantly among the three cohorts of presurgical glycemic control (p = 0.82, p = 0.46, p = 0.51, p = 0.78), respectively. No occurrence of mesh removal was documented. CONCLUSION: In general, diabetes is a marker for increased wound morbidity and complications following complex abdominal wall reconstruction. However, we could not establish a hard cutoff to justify withholding surgery in symptomatic patients based on an arbitrary HbA1C level. We believe this data is important for shared decision-making when considering AWR for symptomatic ventral hernias in diabetic patients.