Long-term cost-effectiveness of insertion of a biological mesh during stoma-site closure: 5-8-year follow-up of the ROCSS randomized controlled trial.

BACKGROUND: The original ROCSS trial demonstrated a significant reduction in clinically detectable incisional hernias at 2 years in patients receiving prophylactic biological mesh during stoma closure. ROCSS-Ex was designed to investigate the 5-8-year cost-effectiveness of mesh in the surviving cohort using an abdominal wall-specific quality of life score. METHODS: Eligible participants from original UK centres were identified. The primary outcome (abdominal wall-specific quality of life) was measured using the HerQLes score and EQ-5D-5L. Assessors remained blind to patients' original allocation, even if the patient was aware of their treatment. RESULTS: Of the original 790 patients, 598 were available for long-term follow-up. HerQLes scores were available for 396 patients (no mesh: 191, mesh: 205). There was no difference in primary outcome between the two groups (mean difference of 1.48, 95% c.i. (-2.35, 5.32), P = 0.45) and no cost benefit of routine insertion of prophylactic biological mesh across the entire cohort in the long term. However, patients who received mesh experienced significantly fewer stoma site complications within the first 3 years after reversal and needed fewer surgical reinterventions (32 versus 54 for the no mesh group; incidence rate ratio of 0.55, 95% c.i. (0.31, 0.97), P = 0.04). CONCLUSIONS: ROCSS-Ex has shown equivocal outcomes for prophylactic mesh insertion versus standard repair on abdominal wall-specific quality of life 5-8 years after surgery. As most reinterventions occurred within the first 3 years post-surgery, there may be a role for prophylactic mesh in a subset of patients who would be most adversely affected by repeated surgery early on. TRIAL REGISTRATION: ISRCTN25584182 (http://www.clinicaltrials.gov).

Clinical outcomes and costs of retromuscular and intraperitoneal onlay mesh techniques in robotic incisional hernia repair.

BACKGROUND: This study aims to compare clinical outcomes and financial cost of intraperitoneal onlay mesh (IPOM) versus retromuscular (RM) repairs in robotic incisional hernia repairs (rIHR). METHODS: Patients who underwent either IPOM or RM elective rIHR from 2012 to 2022 were included. Demographics, operative details, postoperative outcomes, and hospital costs were directly compared. RESULTS: Sixty-nine IPOM and 55 RM were included. Age and body mass index (BMI) did not differ between both groups (IPOM vs RM: 59.3 ± 11.2 years vs. 57.5 ± 14 years, p = 0.423; BMI 34.1 ± 6.3 vs. BMI 33.2 ± 6.9, p = 0.435, respectively). Comorbidities and hernia characteristics were comparable. Extensive lysis of adhesions (> 30 min) was required more often in IPOM (18 vs. 6 in RM, p = 0.034). Defect closure was achieved in 100% of RM vs. 81.2% in IPOM (p < 0.001). Median (interquartile range) postoperative pain score was higher in RM than in IPOM [5(3-7) vs. 4(3-5), respectively, p = 0.006]. Median length of stay (0 day) and same-day discharge rate did not differ between groups (p = 0.598, p = 0.669, respectively). Six (8.7%) patients in the IPOM group versus one (1.8%) patient in the RM group were readmitted to hospital within 30 days postoperatively (p = 0.099). Perioperative complications were higher in IPOM (p = 0.011; 34.8% vs. 14.5% in RM) with higher Comprehensive Complication Index® morbidity scores [0(0-12.2) vs 0(0-0) in RM, p = 0.008)], Clavien-Dindo grade-II complications (8 vs 0 in RM, p = 0.009), and surgical site events (17 vs. 5 in RM, p = 0.024). Within a follow-up period of 57(± 28) months, recurrence rates were similar between both groups. Hospital costs did not differ between groups [IPOM: $9978 (7031-12,926) vs. RM: $8961(6701-11,222), p = 0.300]. Although postoperative complication costs were higher in IPOM ($2436 vs RM: $161, p = 0.020), total costs were comparable [IPOM: $12,415(8700-16,130) vs. RM: $9123(6789-11,457), p = 0.080]. CONCLUSION: Despite retromuscular repairs having lower postoperative complications than intraperitoneal onlay mesh repairs, both techniques offered encouraging results in robotic incisional hernia repair at a comparable total cost.

Early post-operative outcome of pre-pectoral implant-based immediate total breast reconstruction with Polyglactin 910 (Vicryl™) mesh - low cost solution for a low-middle income country.

BACKGROUND: The incidence of breast cancer in Pakistan has been rising with approximately one third of these patients requiring mastectomy. Among breast reconstruction treatment options, the use of Acellular Dermal Matrix (ADM) for pre-pectoral breast implant surgery has proven effective with improved cosmetic outcome. However, due to high cost it cannot be regularly implemented in a developing country like Pakistan. An alternative to ADM, Polyglactin 910 (Vicryl™, Ethicon) mesh has been introduced in pre-pectoral breast reconstructive surgery which has shown to be almost 10 times lower in cost. We set out to determine the frequency of early postoperative complications when using Polyglactin 910 mesh for pre-pectoral implant-based breast reconstruction surgery. METHODS: A single centre, retrospective, chart review was conducted, and a total 28 women were included in the study. Thirty-two pre-pectoral implant-based mastectomies with Polyglactin 910 mesh were performed. Early post-operative outcomes (within 12 months of procedure) including duration of antibiotic use, post-operative infection, implant displacement, flap necrosis, seroma formation, wound dehiscence, hematoma formation, capsular contracture and reconstruction failure, were recorded. RESULTS: Only 4 (12.5%) women experienced early post-operative morbidity. One patient developed a wound dehiscence, which eventually led to reconstruction failure and removal of the implant. Another patient had seroma formation and flap necrosis. None of the patients developed postoperative implant displacement, hematoma formation or capsular contracture in the early post-operative period. CONCLUSION: This study reveals that early post-operative outcomes with Polyglactin 910 mesh in breast reconstructive surgery are few, thus making it a cost effective, reliable, and safe treatment option, especially in developing countries like Pakistan.

Value Analysis of Methods of Inguinal Hernia Repair.

OBJECTIVE: Value is defined as health outcomes important to patients relative to cost of achieving those outcomes: Value = Quality/Cost. For inguinal hernia repair, Level 1 evidence shows no differences in long-term functional status or recurrence rates when comparing surgical approaches. Differences in value reside within differences in cost. The aim of this study is to compare the value of different surgical approaches to inguinal hernia repair: Open (Open-IH), Laparoscopic (Lap-IH), and Robotic (R-TAPP). METHODS: Variable and fixed hospital costs were compared among consecutive Open-IH, Lap-IH, and R-TAPP repairs (100 each) performed in a university hospital. Variable costs (VC) including direct materials, labor, and variable overhead ($/min operating room [OR] time) were evaluated using Value Driven Outcomes, an internal activity-based costing methodology. Variable and fixed costs were allocated using full absorption costing to evaluate the impact of surgical approach on value. As cost data is proprietary, differences in cost were normalized to Open-IH cost. RESULTS: Compared to Open-IH, VC for Lap-IH were 1.02X higher (including a 0.81X reduction in cost for operating room [OR] time). For R-TAPP, VC were 2.11X higher (including 1.36X increased costs for OR time). With allocation of fixed cost, a Lap-IH was 1.03X more costly, whereas R-TAPP was 3.18X more costly than Open-IH. Using equivalent recurrence as the quality metric in the value equation, Lap-IH decreases value by 3% and R-TAPP by 69% compared to Open-IH. CONCLUSIONS: Use of higher cost technology to repair inguinal hernias reduces value. Incremental health benefits must be realized to justify increased costs. We expect payors and patients will incorporate value into payment decisions.

Two-year outcomes of surgeon-tailored trans obturator tape for female stress urinary incontinence: a randomized, comparative, trial with traditional trans obturator tape.

BACKGROUND: Previously, we presented the short-term outcomes of surgeon-tailored mesh in patients with SUI undergoing TOT. In this report, we aim to highlight the two-year outcomes of surgeon tailored mesh in terms of subjective and objective cure rates, as well as late complications. METHODS: We performed a randomized, open-label comparative trial that recruited women with SUI who were scheduled to undergo TOT. Eligible patients were randomly allocated in a 1:1 ratio to receive traditional TOT mesh or surgeon-tailored polyethylene mesh. All patients were followed up for two years. RESULTS: At the end of the follow-up, there were 13 women in the traditional TOT mesh group and 14 patients in the surgeon-tailored polyethylene mesh group. Concerning the primary outcome of the present study, the cure rate was 100% in the surgeon-tailored polyethylene mesh (n = 14) and 92.9% in the traditional TOT mesh group (p = 0.39). One woman reported improved symptoms in the traditional TOT mesh group. There were no reported failures in both groups. Concerning safety, the incidence of de novo urgency was 0% in the surgeon-tailored polyethylene mesh group, compared to 7.1% in the traditional TOT mesh group (p = 0.34). None of the women in both groups reported mesh erosions, dyspareunia, or need for reoperation. CONCLUSION: Surgeon-tailored mesh for patients undergoing TOT is a cost-effective technique, which has comparable long-term outcomes, in terms of cure rate and complications, to the traditional costly meshes. Larger multicentre studies should confirm our results.

Lack of Regulations and Conflict of Interest Transparency of New Hernia Surgery Technologies.

BACKGROUND: Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair. MATERIALS AND METHODS: Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI. RESULTS: A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results. CONCLUSIONS: Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.

Primary surgical management of anterior pelvic organ prolapse: a systematic review, network meta-analysis and cost-effectiveness analysis.

BACKGROUND: Anterior compartment prolapse is the most common pelvic organ prolapse (POP) with a range of surgical treatment options available. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of surgical treatments for the repair of anterior POP. METHODS: We conducted a systematic review of randomised controlled trials comparing surgical treatments for women with POP. Network meta-analysis was possible for anterior POP, same-site recurrence outcome. A Markov model was used to compare the cost-utility of surgical treatments for the primary repair of anterior POP from a UK National Health Service perspective. MAIN RESULTS: We identified 27 eligible trials for the network meta-analysis involving eight surgical treatments tested on 3194 women. Synthetic mesh was the most effective in preventing recurrence at the same site. There was no evidence to suggest a difference between synthetic non-absorbable mesh, synthetic partially absorbable mesh, and biological mesh. The cost-utility analysis, which incorporated effectiveness, complications and cost data, found non-mesh repair to have the highest probability of being cost-effective. The conclusions were robust to model inputs including effectiveness, costs and utility values. CONCLUSIONS: Anterior colporrhaphy augmented with mesh appeared to be cost-ineffective in women requiring primary repair of anterior POP. There is a need for further research on long-term effectiveness and the safety of mesh products to establish their relative cost-effectiveness with a greater certainty. TWEETABLE ABSTRACT: New study finds mesh cost-ineffective in women with anterior pelvic organ prolapse.

A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair.

BACKGROUND: The most effective method for repair of a groin hernia involves the use of a synthetic mesh, but this type of mesh is unaffordable for many patients in low- and middle-income countries. Sterilized mosquito meshes have been used as a lower-cost alternative but have not been rigorously studied. METHODS: We performed a double-blind, randomized, controlled trial comparing low-cost mesh with commercial mesh (both lightweight) for the repair of a groin hernia in adult men in eastern Uganda who had primary, unilateral, reducible groin hernias. Surgery was performed by four qualified surgeons. The primary outcomes were hernia recurrence at 1 year and postoperative complications. RESULTS: A total of 302 patients were included in the study. The follow-up rate was 97.3% after 2 weeks and 95.6% after 1 year. Hernia recurred in 1 patient (0.7%) assigned to the low-cost mesh and in no patients assigned to the commercial mesh (absolute risk difference, 0.7 percentage points; 95% confidence interval [CI], -1.2 to 2.6; P=1.0). Postoperative complications occurred in 44 patients (30.8%) assigned to the low-cost mesh and in 44 patients (29.7%) assigned to the commercial mesh (absolute risk difference, 1.0 percentage point; 95% CI, -9.5 to 11.6; P=1.0). CONCLUSIONS: Rates of hernia recurrence and postoperative complications did not differ significantly between men undergoing hernia repair with low-cost mesh and those undergoing hernia repair with commercial mesh. (Funded by the Swedish Research Council and others; Current Controlled Trials number, ISRCTN20596933.).

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.

The use of mesh for inguinal hernia repair in northern Ghana.

BACKGROUND: Despite the recognition that inguinal hernia (IH) repair is cost-effective, repair rates in low- and middle-income countries remain low. Estimated use of mesh in low- and middle-income countries also remains low despite publications about low-cost, noncommercial mesh. The purpose of our study was to assess the current state of IH repair in the northern and transitional zone of Ghana. MATERIALS AND METHODS: A retrospective review of surgical case logs of IH repairs from 2013 to 2017 in 41 hospitals was performed. Multivariate logistic regression was used to determine predictors of mesh use. RESULTS: Eight thousand eighty male patients underwent IH repair. The range of IH repair in each region was 96 to 295 (overall 123) per 100,000 population. Most cases were performed at district hospitals (84%) and repaired nonurgently (93%) by nonsurgeon physicians (66%). Suture repair was most common (85%) although mesh was used in 15%. The strongest predictor of mesh use was when a surgeon performed surgery (odds ratio [OR] 3.13, P <0.001), followed by surgery being performed in a teaching hospital (OR 2.31, P <0.001). Repair at a regional hospital was a negative predictor of mesh use (OR 0.08, P <0.001) as was the use of general anesthesia (OR 0.40, P = 0.001). CONCLUSIONS: Most IH repairs are performed in district hospitals, by nonsurgeon physicians, and without mesh. Rates of repair and the use of mesh are higher than previous estimates in Ghana and Sub-Saharan Africa but not as high as high-income countries.

Tension-free vaginal mesh surgery versus laparoscopic sacrocolpopexy for pelvic organ prolapse: Analysis of perioperative outcomes using a Japanese national inpatient database.

OBJECTIVE: To compare nationwide outcomes of tension-free vaginal mesh surgery and laparoscopic sacrocolpopexy for the treatment of pelvic organ prolapse in Japan. METHODS: Using the Diagnosis Procedure Combination database, we collected data on female patients who underwent tension-free vaginal mesh surgery or laparoscopic sacrocolpopexy for pelvic organ prolapse from April 2014 to March 2015. We compared the proportion of perioperative adverse events, duration of anesthesia, total costs and postoperative length of stay between the groups. Univariate and multivariate analyses were carried out for age, comorbidity, mesh volume, additional concomitant surgery and hospital volume. RESULTS: We identified 3023 patients, including 2388 who underwent tension-free vaginal mesh surgery, and 635 who underwent laparoscopic sacrocolpopexy. The median age at the time of surgery was significantly higher in the tension-free vaginal mesh group (71 vs 66 years; P < 0.001). The tension-free vaginal mesh group had a higher proportion of all adverse events (7.1% vs 1.8%; P < 0.001) and a higher proportion of genitourinary complications (5.7% vs 1.1%; P < 0.001). The median duration of anesthesia was shorter in the tension-free vaginal mesh group (150 vs 286 min; P < 0.001). The total cost was significantly lower in the tension-free vaginal mesh group. CONCLUSIONS: Both procedures offer favorable results for surgical treatment of pelvic organ prolapse. Overall, the tension-free vaginal mesh procedure seems to represent a good option for high-risk women, such as elderly patients, whereas laparoscopic sacrocolpopexy is useful for younger patients with a higher level of sexual activity.

Prophylactic mesh reinforcement of stomas: a cost-effectiveness meta-analysis of randomised controlled trials.

BACKGROUND: Previous meta-analyses of randomised controlled trials (RCTs) have suggested a reduction in parastomal hernias (PSH) with prophylactic mesh. However, concerns persist regarding variably supportive evidence and cost. We performed an updated systematic review and meta-analysis to inform a novel cost-effectiveness analysis. METHODS: The PubMed, EMBASE and Cochrane Centre Register of Controlled Trials databases were searched (February 2018). We included RCTs assessing mesh reinforcement during stoma formation. We assessed PSH rates, subsequent repair, complications and operative time. Odds ratios (OR) and numbers needed to treat (NNT) were generated on intention to treat (ITT) and per protocol (PP) bases. These then informed cost analysis using 2017 UK/USA reimbursement rates and stoma care costs. RESULTS: Eleven RCTs were included. Four hundred fifty-three patients were randomised to mesh (PP 412), with 454 controls (PP 413). Six studies used synthetic meshes, three composite and two biological (91.7% colostomies; 3.64% ileostomies, 4.63% not specified). Reductions were seen in the number of hernias detected clinically and on computed tomography scan. For the former, ITT OR was 0.23 (95% confidence interval 0.11-0.51; p = 0.0003; n = 11); NNT 4.17 (2.56-10.0), with fewer subsequent repairs: OR 0.29 (0.13-0.64; p = 0.002; n = 7; NNT16.7 (10.0-33.3). Reductions persisted for synthetic and composite meshes. Operative time was similar, with zero incidence of mesh infection/fistulation, and fewer peristomal complications. Synthetic mesh demonstrated a favourable cost profile, with composite approximately cost neutral, and biological incurring net costs. CONCLUSIONS: Reinforcing elective stomas with mesh (primarily synthetic) reduces subsequent PSH rates, complications, repairs and saves money. We recommend that future RCTs compare mesh subtypes, techniques, and applicability to emergency stomas.

Economic and clinical comparison of 2-octyl cyanoacrylate/polymer mesh tape with skin staples in total knee replacement.

OBJECTIVE: To compare economic and clinical outcomes between skin staples and 2-octyl cyanoacrylate plus polymer mesh tape, Dermabond Prineo skin closure system, (SCS) among patients undergoing total knee replacement (TKR). METHOD: Retrospective, observational study using the Premier Healthcare Database, which comprises hospital administrative and billing data for over 700 hospitals in the US. Patients selected for study had an elective hospital admission, with discharge occurring between January 2012 and September 2015, carrying primary ICD-9-CM procedure and diagnosis codes for TKR and osteoarthritis. Patients were classified into two mutually-exclusive groups based on billing records during the index admission: those with billing record(s) for the skin closure system (SCS group); and those with billing record(s) for skin staples (staple group). Primary outcomes were index admission's length of stay (LOS), total hospital costs, and discharge status (skilled nursing facility (SNF)/other versus home/home health-care); exploratory outcomes included operating room time (ORT) during index admission and 30, 60, and 90-day readmissions. The SCS and staple groups were propensity score matched (1:1/nearest neighbour/caliper=0.10) on patient, hospital, and provider characteristics. Multivariable regressions accounting for hospital-level clustering after matching were used to compare outcomes between study groups. RESULTS: Each group comprised 971 patients (1942 total patients; mean age: 65.3 years; female: 63.5%). The groups were generally well-balanced on matching covariates: mean standardised difference calculated across 49 covariates=0.049. Compared with the staple group, the SCS group had statistically significant shorter LOS (2.8 days versus 3.2 days, p=0.002), lower rate of discharge to SNF/other versus home/home health-care (26.4% versus 38.5%, p=0.011), and lower rate of 30, 60, and 90-day readmissions (30-day, 1.8% versus 4.4%, p=0.006; 60-day, 3.0% versus 5.4%, p<0.001; 90-day, 5.4% versus 7.4%, p=0.016). Differences between the groups for other outcomes were not statistically significant. CONCLUSION: Among patients undergoing TKR, use of the SCS was associated with shorter LOS, less resource intensive discharge status, and lower rates of all-cause readmission as compared with skin staples.

Initial Experience With Biologic Polymer Scaffold (Poly-4-hydroxybuturate) in Complex Abdominal Wall Reconstruction.

OBJECTIVE: To evaluate the use of the new absorbable polymer scaffold poly-4-hydroxybutyrate (P4HB) in complex abdominal wall reconstruction. BACKGROUND: Complex abdominal wall reconstruction has witnessed tremendous success in the last decade after the introduction of cadaveric biologic scaffolds. However, the use of cadaveric biologic mesh has been expensive and plagued by complications such as seroma, infection, and recurrent hernia. Despite widespread application of cadaveric biologic mesh, little data exist on the superiority of these materials in the setting of high-risk wounds in patients. P4HB, an absorbable polymer scaffold, may present a new alternative to these cadaveric biologic grafts. METHODS: A retrospective analysis of our initial experience with the absorbable polymer scaffold P4HB compared with a consecutive contiguous group treated with porcine cadaveric mesh for complex abdominal wall reconstructions. Our analysis was performed using SAS 9.3 and Stata 12. RESULTS: The P4HB group (n = 31) experienced shorter drain time (10.0 vs 14.3 d; P < 0.002), fewer complications (22.6% vs 40.5%; P < 0.046), and reherniation (6.5% vs 23.8%; P < 0.049) than the porcine cadaveric mesh group (n = 42). Multivariate analysis for infection identified: porcine cadaveric mesh odds ratio 2.82, length of stay odds ratio 1.11; complications: drinker odds ratio 6.52, porcine cadaveric mesh odds ratio 4.03, African American odds ratio 3.08, length of stay odds ratio 1.11; and hernia recurrence: porcine cadaveric mesh odds ratio 5.18, drinker odds ratio 3.62, African American odds ratio 0.24. Cost analysis identified that P4HB had a $7328.91 financial advantage in initial hospitalization and $2241.17 in the 90-day postdischarge global period resulting in $9570.07 per case advantage over porcine cadaveric mesh. CONCLUSIONS: In our early clinical experience with the absorbable polymer matrix scaffold P4HB, it seemed to provide superior clinical performance and value-based benefit compared with porcine cadaveric biologic mesh.

Cost-effectiveness of groin hernia repair from a randomized clinical trial comparing commercial versus low-cost mesh in a low-income country.

BACKGROUND: Over 200 million people worldwide live with groin hernia and 20 million are operated on each year. In resource-scarce settings, the superior surgical technique using a synthetic mesh is not affordable. A low-cost alternative is needed. The objective of this study was to calculate and compare costs and cost-effectiveness of inguinal hernia mesh repair using a low-cost versus a commercial mesh in a rural setting in Uganda. METHODS: This is a cost-effectiveness analysis of a double-blinded RCT comparing outcomes from groin hernia mesh repair using a low-cost mesh and a commercially available mesh. Cost-effectiveness was expressed in US dollars (with euros in parentheses, exchange rate 30 December 2016) per disability-adjusted life-year (DALY) averted and quality-adjusted life-year (QALY) gained. RESULTS: The cost difference resulting from the choice of mesh was $124·7 (€118·1). In the low-cost mesh group, the cost per DALY averted and QALY gained were $16·8 (€15·9) and $7·6 (€7·2) respectively. The corresponding costs were $58·2 (€55·1) and $33·3 (€31·5) in the commercial mesh group. A sensitivity analysis was undertaken including cost variations and different health outcome scenarios. The maximum costs per DALY averted and QALY gained were $148·4 (€140·5) and $84·7 (€80·2) respectively. CONCLUSION: Repair using both meshes was highly cost-effective in the study setting. A potential cost reduction of over $120 (nearly €120) per operation with use of the low-cost mesh is important if the mesh technique is to be made available to the many millions of patients in countries with limited resources. TRIAL REGISTRATION NUMBER: ISRCTN20596933 (http://www.controlled-trials.com).

Cost of ventral hernia repair using biologic or synthetic mesh.

BACKGROUND: Patients undergoing ventral hernia repair (VHR) with biologic mesh (BioM) have higher hospital costs compared with synthetic mesh (SynM). This study compares 90-d pre- and post-VHR hospital costs (180-d) among BioM and SynM based on infection risk. METHODS: This retrospective National Surgical Quality Improvement Program study matched patient perioperative risk with resource utilization cost for a consecutive series of VHR repairs. Patient infection risks, clinical and financial outcomes were compared in unmatched SynM (n = 303) and BioM (n = 72) groups. Propensity scores were used to match 35 SynM and BioM pairs of cases with similar infection risk for outcomes analysis. RESULTS: BioM patients in the unmatched group were older with higher American Society of Anesthesiologists (ASA) and wound classification, and they more frequently underwent open repairs for recurrent hernias. Wound surgical site infections were more frequent in unmatched BioM patients (P = 0.001) as were 180-d costs ($43.8k versus $14.0k, P < 0.001). Propensity matching resulted in 31 clean cases. In these low-risk patients, wound occurrences and readmissions were identical, but 180-d costs remained higher ($31.8k versus $15.5k, P < 0.001). There were no differences in hospital 180-d diagnostic, emergency room, intensive care unit, floor, pharmacy, or therapeutic costs. However, 180-d operating room services and supply costs were higher in the BioM group ($21.1k versus $7.1k, P < 0.001). CONCLUSIONS: BioM is used more commonly in hernia repairs involving higher wound class and ASA scores and recurrent hernias. Clinical outcomes after low-risk VHRs are similar; SynM utilization in low-risk hernia repairs was more cost-effective.

Low-cost transobturator vaginal tape inside-out procedure for the treatment of female stress urinary incontinence using ordinary polypropylene mesh.

INTRODUCTION AND HYPOTHESIS: The aim of this study is to describe the use of ordinary polypropylene mesh and our modified helical passers through a transobturator vaginal tape inside-out technique (TVT-O) as a low-cost alternative to available commercial kits in the treatment of stress urinary incontinence (SUI) with evaluation of its long-term safety and efficacy. This is important in developing countries due to limited health care resources. METHODS: Tailored (11 × 1.5 cm) polypropylene tape was inserted in 59 women from June 2006 to June 2009 at the Urology Department, Cairo University Hospitals as an open prospective study. SUI was diagnosed by positive cough stress test (CST) and abdominal leak point pressure (ALPP). Patients with post-void residual urine (PVRU) > 100 ml, bladder capacity < 300 ml, or neurological lesions were excluded. The Stress and Urge Incontinence and Quality of Life Questionnaire (SUIQQ), urodynamic parameters, and other variables were compared pre- versus postoperatively with paired t, Wilcoxon signed rank, McNemar, or chi-square tests. RESULTS: The mean age was 47.47 ± 8.52 years. Twenty-one (35.6 %) patients had intrinsic sphincter deficiency (ISD). The mean operative time was 21.22 ± 4.26 min (15-30). Procedures for prolapse were done in four (6 %) patients. Complications were vaginal discharge (6 %), dyspareunia (1 %), groin pain (20 %), urinary tract infection (3 %), obstructive symptoms (1 %), accidental cut of polypropylene suture (1 %) and felt subcutaneous polypropylene sutures (3 %). We had no cases of erosions or de novo urgency. SUIQQ indices improved significantly, while urodynamic parameters showed no significant difference postoperatively. Of the patients, 54 (91 %) were cured and 3 (5 %) improved, while failure was detected in 2 (3 %) patients. CONCLUSIONS: Our technique is safe with excellent 5-year results. It should be considered as a low-cost alternative to available commercial kits in the treatment of SUI mainly for public health systems with few financial resources.

Complex ventral hernia repair using components separation with or without biologic mesh: a cost-utility analysis.

BACKGROUND: A complex ventral hernia requiring abdominal wall reconstruction presents a challenging scenario to the surgeon. The use of biologic mesh in addition to performing a components separation (CS) is controversial. Our goal was to perform the first cost-utility analysis on the use of biologic mesh in addition to performing CS when performing complex ventral hernia repair. METHODS: A comprehensive literature review was conducted to identify published complication and recurrence rates for ventral hernia repairs requiring CS with or without biologic mesh. The probabilities of the most common complications were combined with Medicare Current Procedural Terminology reimbursement codes, diagnosis related group reimbursement codes, and expert utility estimates to fit into a decision model to evaluate the cost utility of CS with and without biologic mesh in reconstructing ventral hernias. RESULTS: The decision model revealed a baseline cost increase of $775.65 and a 0.0517 increase in the quality-adjusted life-years when using biologic mesh yielding an incremental cost-utility ratio of $15,002.90/quality-adjusted life-year. One-way sensitivity analysis revealed that using biologic mesh was cost-effective using Medicare reimbursement rates but not at retail costs. The maximum price of biologic mesh to be cost-effective was $1813.53. CONCLUSIONS: The cost utility of biologic mesh when used with CS in ventral hernia repair is dependent on the financial perspective. It is cost-ineffective for hospitals and physicians paying retail costs but cost-effective for third-party payers providing Medicare reimbursement.

Affordable Care Act: implications in female pelvic medicine and reconstructive surgery.

The Patient Protection and Affordable Care Act (PPACA) of 2010 marks an important milestone in redefining how healthcare will be practiced in the United States for decades to come. This review article will outline the basic concepts associated with the PPACA, including value-based purchasing, pay for performance, accountable care organizations, bundled payments, and patient-centered medical homes, and will discuss how each of these components of the PPACA will impact the subspecialty of Female Pelvic Medicine and Reconstructive Surgery (FPMRS).