Outcomes of primary and recurrent inguinal hernia repair with prosthetic mesh in a single region over 15 years.

BACKGROUND: Sutured inguinal hernia repairs are now uncommon, with evidence suggesting that those augmented with mesh are associated with a lower recurrence rate. We aimed to explore the suggestion that the established use of mesh does indeed lower the rate of operation for recurrence in a single National Health Service region. METHOD: We collected retrospective Office of Population Censuses and Surveys coded data across one region of all primary and recurrent inguinal hernia repairs over 15 years (2004-2019). Electronic records of recurrent repairs were scrutinised to identify year and type of previous primary repair. RESULTS: In total, 7,234 repairs were performed during this time, of which 289 (4%) were for symptomatic recurrence. Operations for primary repair increased year on year (111 in 2004 to 402 in 2019). Frequency of operation for recurrent herniation declined with increasing use of mesh (8.8% in 2004 to 3.5% in 2019). The majority of repairs (73%) for recurrence were by an open approach. As opposed to an open mesh repair, a primary laparoscopic repair was associated with an earlier recurrence. CONCLUSIONS: Inguinal hernia repairs are increasing in frequency but operations for later symptomatic recurrence following an open primary prosthetic mesh repair are not.

Leveraging a statewide quality collaborative to understand population-level hernia care.

BACKGROUND: Although ventral hernia repair (VHR) is extremely common, there is profound variation in operative technique and outcomes. This study describes the results of a statewide registry capturing hernia-specific variables to understand population-level practice patterns. METHODS: Retrospective analysis of adult patients in a new statewide hernia registry undergoing VHR in 2020. RESULTS: 919 patients underwent VHR across 57 hospitals and 279 surgeons. Hernia width was <2 cm in 233 (25%) patients, 2-5 cm in 420 (46%) patients, 5-10 cm in 171 (19%) patients, and >10 cm in 95 (10%) patients. Mesh was used in 79% of cases and varied in use from 53% of hernias <2 cm to 95% of hernias >10 cm. The most common mesh type was synthetic non-absorbable (46%), followed by synthetic absorbable mesh (37%). The incidence of complications was significantly associated with hernia width. CONCLUSIONS: A population-level, hernia-specific database captured operative details for 919 patients in 1 year. There was significant variation in mesh use and outcomes based on hernia size. These nuanced data may inform higher quality clinical practice.

Perceptions and understanding about mesh and hernia surgery: What do patients really think?

BACKGROUND: Surgical mesh and hernia repair have come under increasing scrutiny with large amounts of press, Internet, and social media reportage regarding ongoing mesh litigation, recalls, and patient testimonials. The aim of this study was to evaluate patient perceptions of mesh in hernia surgery. METHODS: A 16-question survey was given to patients presenting for hernia surgery at a tertiary hernia center by trained data analysts before surgeon interaction. RESULTS: Two hundred and two patients were surveyed. Patients believed mesh caused complications (45.1%) and reported concerns about mesh (38.2%). Those who performed their own research, females, and patients with recurrent hernias were more likely to have concerns about mesh (P ≤ 0.03). Most patients (81.7%) thought they were at average risk or less for complications; patients with recurrent hernias (versus primary hernias) and incisional hernias (compared with inguinal or umbilical hernias) had more negative outlooks on complications (all P < .05). Recovery expectations varied, but the failed repair and incisional hernia groups were more likely to expect prolonged recovery (>3 months) (all P < .05). After surgeon-directed education and a mesh education handout, all but one patient agreed to and underwent a mesh repair as indicated. CONCLUSION: Patients had concerns about mesh and were aware of mesh related complications. Patients performing their own research, as well as females and recurrent hernia patients, had worse perceptions of mesh. Recurrent and incisional hernia patients had greater concerns about complications, recurrence, and recovery. Preoperative education concerning mesh and mesh choice for each operation eased patient anxiety.

First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study.

BACKGROUND: Even though meshes and matrices are widely used in breast reconstruction, there is little high-quality scientific evidence for their risks and benefits. The aim of this study was to compare first-year surgical complication rates in implant-based immediate breast reconstruction with a biological mesh with that of a synthetic mesh, in the same patient. METHODS: This study is a clinical, randomized, prospective trial. Patients operated on with bilateral mastectomy and immediate breast reconstruction were randomized to biological mesh on one side and synthetic mesh on the other side. RESULTS: A total of 48 breasts were randomized. As the synthetically and the biologically reconstructed breasts that were compared belonged to the same woman, systemic factors were exactly the same in the two groups. The most common complication was seroma formation with a frequency of 38% in the biological group and 3.8% in the synthetical group (p = .011). A higher frequency of total implant loss could be seen in the biologic mesh group (8.5% vs. 2%), albeit not statistically significant (p = .083). CONCLUSIONS: In the same patient, a synthetic mesh seems to yield a lower risk for serious complications, such as implant loss, than a biological mesh.

Trends of Mesh Utilization for Stress Urinary Incontinence Before and After the 2011 Food and Drug Administration Notification Between FPMRS-Certified and Non-FPMRS-Certified Physicians: A Statewide All-Payer Database Analysis.

OBJECTIVES: To investigate the utilization of mesh slings for stress urinary incontinence (SUI) across time - before and after the 2011 US Food and Drug Administration (FDA) public health notification regarding an increase in adverse events related to transvaginal mesh (TVM) for pelvic organ prolapse (POP) repair - and among FPMRS-certified urologists and gynecologists and non-FPMRS counterparts using a statewide database. METHODS: The New York Statewide Planning and Research Cooperative System all-payer database was utilized to extract outpatient Current Procedural Terminology procedure codes for SUI mesh sling utilization and revision or removal performed between 2007 and 2015. RESULTS: After the 2011 FDA warning on POP with TVM, sling placement decreased by 43% from 5214 cases in 2011 to 2958 in 2015. However, over the study period, the rate of sling revision remained stable relative to total sling placement. The rise and fall in mesh sling usage for SUI was primarily driven by non-FPMRS providers. FPMRS providers performed a higher proportion of sling procedures. The number of FPMRS physicians also increased from 2011 to 2015, and each individual physician had a higher median case volume for sling placements and revisions. CONCLUSION: In New York state, utilization of mesh slings for SUI has significantly decreased since the 2011 FDA public health notification, without any specific warning for the utilization of mesh in this setting. This trend was mainly driven by a decrease in mesh usage among non-FPMRS physicians, although the specific causality is likely complex.

Complications of Pelvic Organ Prolapse Surgery in the 2015 Finnish Pelvic Organ Prolapse Surgery Survey Study.

OBJECTIVE: To describe the major complications of pelvic organ prolapse (POP) surgery in Finland. METHODS: The Finnish Pelvic Organ Prolapse Surgery Survey 2015 study is a prospective cohort of POP surgeries performed in Finland in 2015. Perioperative, postoperative, and late complications during 1 year of follow-up were compared among native tissue repair, transvaginal mesh, and abdominal mesh surgery. Major complications were assessed using the Clavien-Dindo grading system. Predictive factors for major complications were studied with logistic regression analysis. RESULTS: Within 1 year after POP surgery, 396 (11.2%) of 3,515 women had at least one complication: 10.9% after native tissue, 11.7% after transvaginal mesh, and 13.5% after abdominal mesh repair. The majority of complications occurred within 2 months after surgery and postoperative infection (4.3%) and bleeding or hematoma (2.6%) were the most frequent. The incidence of organ injuries was low. Mesh-augmented surgery was associated with significantly higher rates of bladder and bowel injuries than native tissue surgery. Complication-related reoperations occurred significantly more often after abdominal mesh repair than native tissue surgery (5.2% vs 1.8%, P=.001). Mesh-related complications were diagnosed more often after transvaginal mesh repair. The overall rate of major complications (Clavien-Dindo grades III-V) was 3.3%. Abdominal mesh surgery was associated with the highest rate of major adverse events (8.8% vs native tissue repair 2.6% and transvaginal mesh 4.9%). The incidence of Clavien-Dindo grade IV or V complications was rare (less than 0.6%). Mesh surgery (transvaginal mesh adjusted odds ratio [aOR] 2.23, 95% CI 1.31-3.80, and abdominal mesh aOR 3.02, 95% CI 1.67-5.46), longer operating time (aOR 2.84, 95% CI 1.78-4.53), prior POP surgery (aOR 1.68, 95% CI 1.00-2.81) and difficult surgery (aOR 2.75, 95% CI 1.63-4.62) were associated with an increased risk for occurrence of major complications. CONCLUSION: Serious adverse events were rare regardless of the operative approach. However, mesh-augmented surgery was associated with higher risk for major complications.

Perioperative opioid prescriptions associated with stress incontinence and pelvic organ prolapse surgery.

BACKGROUND: There is an opioid epidemic in the United States with a contributing factor of opioids being prescribed for postoperative pain after surgery. OBJECTIVE: Among women who underwent stress urinary incontinence and pelvic organ prolapse surgeries, our primary objective was to determine the proportion of women who filled perioperative opioid prescriptions and to compare factors associated with these opioid prescriptions. We also sought to assess the risk of prolonged opioid use through 1 year after stress urinary incontinence and pelvic organ prolapse surgeries. STUDY DESIGN: Using a population-based cohort of commercially insured individuals in the 2005-2015 IBM MarketScan databases, we identified opioid-naive women ≥18 years who underwent stress urinary incontinence and/or pelvic organ prolapse procedures based on Current Procedural Terminology codes. We defined the perioperative period as the window beginning 30 days before surgery extending until 7 days after surgery. Any filled opioid prescription in this window was considered a perioperative prescription. For our primary outcome, we reported the proportion of opioid-naive women who filled a perioperative opioid prescription and reported the median quantity dispensed in the perioperative period. We also assessed demographic and perioperative factors associated with perioperative opioid prescription fills. Previous studies have defined prolonged use as the proportion of women who fill an opioid prescription between 90 and 180 days after surgery. We report this estimate as well as continuous opioid use, defined as the proportion of women with ongoing monthly opioid prescriptions filled through 1 year after stress urinary incontinence and/or pelvic organ prolapse surgery. RESULTS: Among the 217,460 opioid-naive women who underwent urogynecologic surgery, 61,025 (28.1%) had pelvic organ prolapse and stress urinary incontinence surgeries, 85,575 (39.4%) had stress urinary incontinence surgery without pelvic organ prolapse surgery, and 70,860 (32.6%) had pelvic organ prolapse surgery without stress urinary incontinence surgery. Overall, 167,354 (77.0%) filled a perioperative opioid prescription, and the median quantity was 30 pills (interquartile range, 20-30). In a multivariate regression model, younger age, pelvic organ prolapse surgery with or without stress urinary incontinence surgery, abdominal route, hysterectomy, and mesh use remained significantly associated with opioid prescriptions filled. Among those with a filled perioperative opioid prescription, the risk of prolonged use defined as an opioid prescription filled between 90 and 180 days was 7.5% (95% confidence interval, 7.3-7.6). However, the risk of prolonged use defined as continuous use with at least 1 monthly opioid prescription filled after surgery was significantly lower: 1.2% (1.13-1.24), 0.32% (0.29-0.35), 0.06% (0.05-0.08), and 0.04% (0.02-0.05) at 60, 90, 180, and 360 days after surgery, respectively. CONCLUSION: Among privately insured, opioid-naive women undergoing stress urinary incontinence and/or pelvic organ prolapse surgery, 77% of women filled an opioid prescription with a median of 30 opioid pills prescribed. For prolonged use, 7.5% (95% confidence interval, 7.3-7.6) filled an opioid prescription within 90 to 180 days after surgery, but the rates of continuously filled opioid prescriptions were significantly lower at 0.06% (95% confidence interval, 0.05-0.08) at 180 days and 0.04% (95% confidence interval, 0.02-0.05) at 1 year after surgery.

Complications Following the Use of Biologic Mesh in Ileostomy Closure: A Retrospective, Comparative Study.

Prophylactic placement of mesh in the abdominal wall during ileostomy closure can decrease the rate of hernia formation. However, few studies have evaluated the safety of biologic mesh in ileostomy closure. PURPOSE: This study aimed to investigate the safety of biologic mesh in ileostomy closure, specifically the need to remove the mesh due to infection. The rate of surgical site infection (SSI), incisional hernia, surgical site occurrence ([SSO] including seroma and hematoma), and wound pain between primary closure and mesh closure groups also were investigated. METHODS: Using a retrospective study design, data from all consecutive patients who underwent ileostomy closure from January 2015 to June 2016 at the Hanyang University Hospital, Seoul, Republic of Korea, were analyzed. Patients with stage IV colorectal cancer, who were older than 85 years, or who experienced intestinal perforation during the procedure were excluded. Demographic (age, sex, body mass index [BMI], underlying disease) and clinical characteristics as well as SSI, SSO, length of hospital stay, use of additional analgesics, white blood cell count, C-reactive protein, and visual analog scale (VAS) pain scores (noted on days 1, 3, 5, and 14) were abstracted and compared. Clinical and surgical variables were compared using the Mann-Whitney U test, the χ2-test, or Fisher's exact test, depending on the nature of the data. RESULTS: Of the 38 patients who underwent ileostomy closure, 33 (18 [54.5%] who received primary closure and 15 [45.5%] who received mesh closure) were included for analysis. Patient, surgical, and clinical characteristics were not significantly different, but the mean age of the primary closure group was significantly higher than that of the mesh closure group (71 ± 9 vs. 62 ± 10 years old; P = .014). The median follow-up duration was 25 months (interquartile range 18.0-31.5 months). Six (6) complications were observed in 5 patients in the primary closure group, and 8 complications in 5 patients were noted in the mesh closure group (27.8% vs. 33.3%; P = 1.000). None of the cases required removal of the biologic mesh due to mesh-related infectious complication. Two (2) SSIs occurred in the primary closure group (11.1% vs. 0%; P = .489). Three (3) patients experienced a postoperative incisional hernia (9.1%) - 1 in the primary closure group and 2 in the mesh closure group (5.6% vs. 13.3%; P = .579). No statistically significant differences in pain or length of hospitalization were noted. CONCLUSION: No mesh-related infectious complications required biologic mesh removal, and no significant differences were noted in SSI, incisional hernia, and wound pain between the primary closure and mesh closure groups. Although not significantly different, the higher rates of hernia and SSOs in the mesh group require further study.

Evaluation of single-incision apical vaginal suspension for treatment of pelvic organ prolapse.

OBJECTIVE: To present a comprehensive evaluation of anterior/apical and/or posterior prolapse repair systems with a focus on safety and surgical efficacy. METHODS: Two hundred and twenty women with pelvic organ prolapse (POP) stage II-IV were referred for single-incision transvaginal mesh procedures in a single institution. Pre- and postoperative assessments included pelvic examination, urodynamic studies, and personal interviews about patients' quality of life and urinary symptoms. RESULTS: The anatomical success rate was 92.3 % (203/220), regardless of primary or de-novo POP, at 12-38 month follow-up. The POP quantification parameters, except total vaginal length, improved significantly after surgery (p < 0.05). Complications included bladder injury (one case), mesh exposure (six cases) and urinary retention that required intermittent catheterization (five cases). There were no cases of bowel injury during surgery. The results indicated that 29 % of patients had de-novo stress urinary incontinence and 7.7 % of patients had de-novo POP after surgery. CONCLUSION: The apical vaginal suspension system is a safe and effective procedure, creating good anatomical restoration and significant improvement in quality of life. However, the rate of de-novo POP in the anterior compartment of the vagina (31.8 %) seems high after treatment with apical and posterior prolapse repair systems.

Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs.

OBJECTIVE: To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs. METHODS: We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis. RESULTS: We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4-6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27-1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2-9.3%) in the mesh group and 6.3% (5.9-6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications. CONCLUSION: Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.

Feasibility of vaginal mesh for anterior vaginal wall prolapse in an ambulatory setting: A retrospective case series.

INTRODUCTION: Vaginal mesh has been proven to be an effective aid in the treatment of cystocele. Could an ambulatory approach be feasible for the Uphold Lite®-mesh? HYPOTHESIS: We investigate the feasibility of an ambulatory approach of Uphold Lite® insertion in a well-selected population. Risk factors for a non-successful ambulatory approach are identified. METHODOLOGY: We conducted a retrospective case series of 236 women who underwent Uphold Lite® vaginal mesh insertion for the treatment of pelvic organ prolapse at our center. Indications for surgery were symptomatic anterior and/or apical prolapse, stages POPQ≥2. We compared women having an ambulatory approach, to those having a one day hospitalization planned but needed to stay. Comparisons between percentages were calculated using the chi-square or Fisher's exact test, depending on the number of women in each group. The mean comparisons were performed using the Student t-test, and the median test comparisons by the Kruskal-Wallis test. A difference was considered significant if p<0.05. RESULTS: The most common reason for staying (85.7% of all ambulatory failures) after Uphold® surgery is the presence of an elevated post void residual. This complication was more found in the following: surgery in the afternoon, use of high-dose morphinics in general anesthesia, and in women with a higher parity. CONCLUSIONS: Our study shows that Uphold® surgery in a one-day setting is feasible and safe. Women desiring this approach should be counselled on the 42.6% risk of one-day failure though, mostly due to non-validation of a post void residual. General anesthesia with high-dose morphinics, a higher parity, and surgery in the afternoon are risk factors for failure of an ambulatory protocol.

Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort.

INTRODUCTION AND HYPOTHESIS: As the long-term complications of synthetic mesh become increasingly apparent, re-evaluation of alternative graft options for pelvic organ prolapse (POP) repairs is critical. We sought to compare the long-term reoperation rates of biologic and synthetic grafts in POP repair. METHODS: Using the California Office of Statewide Health Planning and Development database, we identified all women who underwent index inpatient POP repair with either a synthetic or biologic graft between 2005 and 2011 in the state of California. ICD-9 and CPT codes were used to identify subsequent surgeries in these patients for either recurrent POP or a graft complication. RESULTS: A total of 14,192 women underwent POP repair with a biologic (14%) or synthetic graft (86%) during the study period. Women with biologic grafts had increased rates of surgery for recurrent pelvic organ prolapse (3.6% vs 2.5%, p = 0.01), whereas women with synthetic grafts had higher rates of repeat surgery for a graft complication (3.0 vs 2.0%, p = 0.02). There were no significant differences between the overall risk of repeat surgery between the groups (5.7% vs 5.6%, p = 0.79). These effects persisted in multivariate modeling. CONCLUSIONS: We demonstrate in a large population-based cohort that biologic grafts are associated with an increased rate of repeat surgery for POP recurrence whereas synthetic mesh is associated with an increased rate of repeat surgery for a graft complication. These competing risks result in an equivalent overall any-cause repeat surgery rate between the groups. These data suggest that neither type of graft should be excluded from use and encourage a personalized risk assessment.

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

The management of perineal hernia following abdomino-perineal excision for cancer.

PURPOSE: Perineal hernia (PH) is a tardive complication following abdomino-perineal resection (APR). Many repair methods are described and evidences are lacking. The aim of this study was to report PH management, analyze surgery outcomes and review the available literature. METHODS: We retrospectively included all consecutive PH repair after APR performed between 2001 and 2017. We recorded data on APR surgery, PH symptoms and repair, and follow-up (recurrence and morbidity). Literature review included published articles on PubMed between 1960 and 2017. RESULTS: 24 PH repairs were included. The approach was perineal N = 16, abdominal N = 5 and combined N = 3. A biological mesh was used for 17, a synthetic for 5 and a flap for 2 patients. The median follow-up was 25 months. Overall morbidity was 37.5% (N = 9): 37.5% for the perineal, 20% for the abdominal, and 66.7% for the combined approach. Complications occurred in 35.3% of biological and 20% of synthetic mesh repairs. Recurrence rate was 41.7%, similar for biological (n = 8, 47.1%) and synthetic meshs (n = 2; 40%). No recurrence occurred in the flap group. Depending of the approach, we found 50% for perineal (n = 8) and 40% of the abdominal cohort (N = 2). Among twelve studies, recurrence rates ranged from 0 to 66.7%. Abdominal or laparoscopic approach with synthetic mesh was associated with less recurrences (0 and 12.5% respectively) and complications (37.5% and 9.5%). CONCLUSIONS: Recurrences following PH repair are high irrespective of the repair technique. More studies are necessary to identify PH risk factors and decide the appropriate perineal reconstruction.

A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set.

BACKGROUND: Recent systematic reviews have demonstrated wide variations on outcome measure selection and outcome reporting in trials on surgical treatments for anterior, apical and mesh prolapse surgery. A systematic review of reported outcomes and outcome measures in posterior compartment vaginal prolapse interventions is highly warranted in the process of developing core outcome sets. OBJECTIVE: To evaluate outcome and outcome measures reporting in posterior prolapse surgical trials. SEARCH STRATEGY: We searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL). SELECTION CRITERIA: Randomized trials evaluating the efficacy and safety of different surgical interventions for posterior compartment vaginal prolapse. DATA COLLECTION AND ANALYSIS: Two researchers independently assessed studies for inclusion, evaluated methodological quality, and extracted relevant data. Methodological quality, outcome reporting quality and publication characteristics were evaluated. MAIN RESULTS: Twenty-seven interventional and four follow-up trials were included. Seventeen studies enrolled patients with posterior compartment surgery as the sole procedure and 14 with multicompartment procedures. Eighty-three reported outcomes and 45 outcome measures were identified. The most frequently reported outcomes were blood loss (20 studies, 74%), pain (18 studies, 66%) and infection (16 studies, 59%). CONCLUSIONS: Wide variations in reported outcomes and outcome measures were found. Until a core outcome set is established, we propose an interim core outcome set that could include the three most commonly reported outcomes of the following domains: hospitalization; intraoperative, postoperative urinary, gastrointestinal, vaginal and sexual outcomes; clinical effectiveness. PROSPERO: CRD42017062456.

Use of real-world registry data: a hernia mesh example.

PURPOSE: Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices. METHODS: Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types. RESULTS: Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results. CONCLUSIONS: High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.

Management of the uncomplicated primary inguinal hernia in 2019: the practice amongst members of the British Hernia Society.

INTRODUCTION: The aim of this study was to survey the current practice of UK-based hernia surgeons in elective inguinal hernia repair. MATERIALS AND METHODS: A questionnaire was created using SurveyMonkey™ and sent electronically to registered members of the British Hernia Society. RESULTS: A total of 368 responses were obtained (a response rate of 55%); 83% were consultant surgeons, 91% were male and 91% stated that they had an interest in laparoscopic surgery. For an uncomplicated inguinal hernia in a male patient, 60% would perform an open Lichtenstein repair, 20% trans-abdominal pre-peritoneal repair and 20% totally extra-peritoneal repair. In a female patient, 54% would perform an open Lichtenstein repair, 25% trans-abdominal pre-peritoneal repair and 21% totally extra-peritoneal repair. 90% always use mesh in inguinal hernia repair. 93% of surgeons rarely or never perform a tissue repair. CONCLUSIONS: Despite recent controversy, UK surgeons support the use of mesh in the repair of inguinal hernias with an open Lichtenstein repair being the most common choice. There has only been a modest increase in the use of laparoscopic surgery over the past 20 years.

Mesh versus suture repair of primary inguinal hernia in Ghana.

Background: Most patients in Ghana undergo suture repair for primary inguinal hernia. Although there is strong evidence from high-income country settings to indicate superiority of mesh repair for inguinal hernia, the evidence to support the safety and effectiveness of mesh repair in the Ghanaian setting is limited. This study aimed to compare hernia recurrence rates following suture versus mesh repair in Ghana. Methods: Men aged 18 years or over presenting with symptomatic, reducible inguinal hernias were included. Over the first 6 months all consecutive patients were enrolled prospectively and underwent a standardized suture repair; an equal number of patients were subsequently enrolled to undergo mesh repair. The primary outcome was hernia recurrence within 3 years of the index operation. Multivariable analysis was adjusted for age and right or left side. Adjusted odds ratios (ORs) with 95 per cent confidence intervals are reported. Results: A total of 116 sutured and 116 mesh inguinal hernia repairs were performed. Three years after surgery, follow-up data were available for 206 of the 232 patients (88·8 per cent). Recurrence occurred significantly more frequently in the suture repair group (23 of 103, 22·3 per cent) than in the mesh group (7 of 103, 6·8 per cent) (P = 0·002). In multivariable analysis, suture repair was independently associated with an increased risk of recurrence (OR 4·51, 95 per cent c.i. 1·76 to 11·52; P = 0·002). Conclusion: In Ghana, mesh inguinal hernia repair was associated with reduced 3-year recurrence compared with sutured repair. Controlled dissemination across Ghana should now be assessed.

Value Improvement and Resource Utilization in Complex Abdominal Wall Reconstruction.

Although recommendations help guide surgeons' mesh choice in abdominal wall reconstruction (AWR), financial and institutional pressures may play a bigger role. Standardization of an AWR algorithm may help reduce costs and change mesh preferences. We performed a retrospective review of high- and low-risk patients who underwent inpatient AWR between 2014 and 2016. High risk was defined as immunosuppression and/or history of infection/contamination. Patients were stratified by the type of mesh as biologic/biosynthetic or synthetic. These cohorts were analyzed for outcome, complications, and cost. One hundred twelve patients underwent complex AWR. The recurrence rate at two years was not statistically different between high- and low-risk cohorts. No significant difference was found in the recurrence rate between biologic and synthetic meshes when comparing both high- and low-risk cohorts. The average cost of biologic mesh was $9,414.80 versus $524.60 for synthetic. The estimated cost saved when using synthetic mesh for low-risk patients was $295,391.20. In conclusion, recurrence rates for complex AWR seem to be unrelated to mesh selection. There seems to be an excess use of biologic mesh in low-risk patients, adding significant cost. Implementing a critical process to evaluate indications for biologic mesh use could decrease costs without impacting the quality of care, thus improving the overall value of AWR.

Primary Umbilical Hernia Repair: A Large-Volume Single-Surgeon Study.

There are conflicting views regarding techniques for repair of small umbilical hernias (UHs). Here, we compare the recurrence rate in primary repair with that reported for mesh repair by examining a single surgeon's practice at a large medical center with a comprehensive electronic medical record. A six-year retrospective review of primary UH repairs between January 2012 and December 2017 at Kaiser Permanente Los Angeles Medical Center was undertaken. Patients were identified through a database search of the electronic medical record. The primary endpoint of UH recurrence was examined; median follow-up was 3.4 years. Primary, elective UH repair was performed in 244 patients; 71 per cent of hernias were small (<2 cm). The total number of recurrences was seven (3%). The t test analysis showed significant differences in the average size of hernia defects between those with recurrences (2 cm) and those without (1.4 cm), P < 0.05. Primary repair affords low infection and recurrence rates, comparable to those reported for mesh repair. Our single-surgeon/large-volume study contributes to the evidence that primary UH repair is a safe and durable method, with low risk of recurrence. The use of absorbable monofilament suture, and selection for lower BMI and smaller hernia sizes proved to be effective.