Autologous versus synthetic midurethral transobturator sling: A systematic review and meta-analysis of outcomes.

INTRODUCTION: There have been concerns around the use of synthetic mesh for stress urinary incontinence (SUI) surgery with a renewed interest in the use of autologous tissues. Recently, an autologous transobturator sling (aTOT) has been described, but the comparative data with synthetic transobturator sling (sTOT) is limited. The objective of this systematic review and meta-analysis was to assess the outcome of aTOT and compare it with sTOT. METHODS: A systematic search of PubMed, Scopus, and Web of Science databases was performed and all articles available up to December 31, 2023 were screened. Studies reporting on the outcomes of aTOT and those comparing aTOT with sTOT were included. This review was performed as per Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. RESULTS: Eleven studies evaluating 323 patients that met the criteria were included in the final analysis, of which 6 were single arm (155 patients) and 5 were comparative. In single-arm studies, the pooled success rate, defined as negative cough stress test at 12 months follow-up was 96.8%, 3.8% had postoperative urinary retention, 6.1% had graft site-related complications and 7.6% required additional intervention for persistent SUI. The overall complication rate was 20.6% and there were no Clavien III-V complications. aTOT had similar success and complication rates when compared with sTOT but had a significantly longer operative time (weighted mean difference: 22.35 min, p < 0.00001) and superior sexual function outcomes. CONCLUSIONS: aTOT, at short-term follow-up (12 months), has similar efficacy and complication rates when compared to sTOT. However, given that the data is limited and not of very good quality, and the fact that long-term follow-up is not available, further studies are required to better define the role of aTOT in the management of female patients with SUI.

Sacrocolpopexy: Alternatives to Mesh Grafts.

INTRODUCTION AND HYPOTHESIS: The ongoing pelvic mesh controversy, coupled with a regulatory pause in using pelvic mesh in some countries, has created a need for mesh-free alternatives for sacrocolpopexy (SCP). This article provides an overview of mesh-free alternatives for SCP. METHODS: MEDLINE and PubMed searches were conducted to identify studies reporting on autologous and non-autologous biologic grafts for SCP. Identified studies were reviewed by two of the authors (CY and MR). RESULTS: Emerging evidence on autologous fascia lata (AFL) and rectus sheath (ARS) for SCP is promising, with low donor site morbidity. Non-autologous biologic grafts for SCP are mostly reported to be inferior to mesh. CONCLUSIONS: Emerging evidence suggests that AFL and ARS might be safe and effective alternative options to mesh SCP. The main advantages of AFL for SCP over ARS are laparoscopy or robot-assisted laparoscopy approaches, and that a larger graft can be safely harvested. The benefits of utilising allografts and xenografts are limited by their reduced durability compared with mesh and patient acceptability.

Early safety and efficiency outcomes of a novel interdisciplinary laparoscopic resection rectopexy combined with sacrocolpopexy for women with obstructive defecation syndrome and pelvic organ prolapse: a single center study.

BACKGROUND: Obstructive defecation syndrome (ODS) defines a disturbed defecation process frequently associated with pelvic organ prolapse (POP) in women that substantially compromises quality of life. Conservative management offers limited relief and a surgical intervention may be required. This is characterized by individual approaches. AIM OF THE STUDY: This retrospective single center study evaluated the surgical and clinical short-term outcome of a novel interdisciplinary laparoscopic resection rectopexy (L-RRP) with mesh- sacrocolpopexy (L-SCP) for women suffering from ODS and POP. METHODS: The study participants underwent surgery in an interdisciplinary laparoscopic approach. Safety was the primary endpoint, assessed via postoperative morbidity classified by Clavien-Dindo scale. Secondary outcomes included evaluation of bowel function, fecal and urinary incontinence and pelvic organ prolapse status at 12 months follow-up. Additionally, a biological mesh (BM) was offered to women, who asked for an alternative to synthetic mesh material (SM). RESULTS: Of the 44 consecutive patients requiring surgery for ODS and POP, 36 patients underwent the interdisciplinary surgical approach; 28 patients with SM and 8 patients with BM. In total 5 complications occurred, four of them were classified as minor. One minor complication was observed in the BM group. One anastomotic leakage occurred in the SM group. The two ODS scores, the bowel dysfunction score, and the incontinence score improved significantly (p = 0.006, p = 0.003, p < 0.001, and p = 0.0035, respectively). Pelvic floor anatomy was fully restored (POP-Q 0) for 29 (80%) patients after surgery. 17 patients (47%) suffered from urinary incontinence before surgery, which was restored in 13 patients (76.5%). CONCLUSIONS: The interdisciplinary approach with L-RRP and L-SCP and the use of a BM in a small subgroup were technically feasible, safe, and effective in this single center setting. The study's retrospective design, the small sample size and the lack of comparators limit the generalizability of the findings requiring future randomized trials. TRIAL REGISTRATION: Retrospectively registered at clinicaltrials.gov, trial number NCT05910021, date of registration 06/10/2023.

Current Global Trends in Prepectoral Breast Reconstruction.

Implant-based breast reconstruction (IBBR) is the most frequently performed procedure for breast reconstruction following mastectomy, which involves the surgical placement of breast implants. The approach to breast reconstruction can be divided into two main categories, namely prepectoral breast reconstruction (PPBR) and subpectoral breast reconstruction (SPBR), based on the implant plan and placement technique. In recent years, there has been a significant surge in the popularity of prepectoral implant-based breast reconstruction, where the implants are positioned above the chest muscle, as opposed to beneath it in the subpectoral approach. However, despite this growing preference, there is a lack of comprehensive data regarding the national trends in the utilization of this technique, thus necessitating further investigation. This narrative review aims to ascertain the current global patterns linked to prepectoral breast reconstruction and elucidate the considerations surrounding patient and implant selection, reconstructive techniques, the utilization of meshes in prepectoral reconstruction, the ensuing outcomes and complications, the ramifications of radiotherapy, and the potential advantages of integrating fat infiltration into the implementation of this technique in breast reconstruction with a focus on published papers in last five years. Conclusion: Prepectoral breast reconstruction has emerged as an appropriate surgical option for individuals seeking breast reconstruction. This development can be attributed to the recent progress made in implant technology, which has significantly enhanced the outcomes of this procedure. Additionally, advancements in mastectomy techniques, autologous fat grafting, and the use of acellular dermal matrices (ADMs) have also played a vital role in improving the aesthetic results of prepectoral breast reconstruction. As a result, the significance and effectiveness of this technique in the field of breast reconstruction have been firmly established, making it an essential component of the overall armamentarium available to plastic surgeons for breast reconstruction purposes.

Mesh Type With Ventral Hernia Repair: A Systematic Review and Meta-analysis of Randomized Trials.

INTRODUCTION: Synthetic mesh is widely utilized for clean ventral hernia repair; however, it is unclear if synthetic mesh provides the same benefits with high-risk patients or during contaminated cases. Many surgeons use biologic mesh in these settings, but there is little evidence to support this practice. Our objective was to compare the clinical outcomes of utilizing biologic mesh versus synthetic mesh during ventral hernia repair. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, a review of the literature was conducted using Cochrane library, EMBASE, Clinicaltrials.gov, and PubMed for randomized controlled trials published that compared biologic versus synthetic mesh during ventral hernia repair. The primary outcome was major complications defined as deep or organ space surgical site infection, reoperations, and hernia recurrences. RESULTS: Of 1889 manuscripts screened, four publications were included. The four studies included a total of 758 patients, with 381 receiving biologic mesh and 377 receiving synthetic mesh. Compared to biologic mesh, synthetic mesh had lower rates of major complications (38.6% versus 23.4, risk ratio = 0.55, 95% confidence interval = 0.35 to 0.86, P = 0.009) and hernia recurrence (24.5 % versus 10.3%, risk ratio = 0.44, 95% confidence interval = 0.28 to 0.69, P = 0.004). In addition, there was a lower percentage of surgical site infection and reoperation in the synthetic mesh group. CONCLUSIONS: Contrary to current surgical teaching, placement of permanent synthetic mesh into a contaminated field yielded rates of complications that were comparable or reduced compared to biologic mesh.

Comparative long-term effectiveness between ventral hernia repairs with biosynthetic and synthetic mesh.

BACKGROUND: Debate exists regarding the most appropriate type of mesh to use in ventral hernia repair (VHR). Meshes are broadly categorized as synthetic or biologic, each mesh with individual advantages and disadvantages. More recently developed biosynthetic mesh has characteristics of both mesh types. The current study aims to examine long-term follow-up data and directly compare outcomes-specifically hernia recurrence-of VHR with biosynthetic versus synthetic mesh. METHODS: With IRB approval, consecutive cases of VHR (CPT codes 49,560, 49,561, 49,565, and 49,566 with 49,568) performed between 2013 and 2018 at a single institution were reviewed. Local NSQIP data was utilized for patient demographics, perioperative characteristics, CDC Wound Class, comorbidities, and mesh type. A review of electronic medical records provided additional variables including hernia defect size, postoperative wound events to six months, duration of follow-up, and incidence of hernia recurrence. Longevity of repair was measured using Kaplan-Meier method and adjusted Cox proportional hazards regression. RESULTS: Biosynthetic mesh was used in 101 patients (23%) and synthetic mesh in 338 (77%). On average, patients repaired using biosynthetic mesh were older than those with synthetic mesh (57 vs. 52 years; p = .008). Also, ASA Class ≥ III was more common in biosynthetic mesh cases (70.3% vs. 55.1%; p = .016). Patients repaired with biosynthetic mesh were more likely than patients with synthetic mesh to have had a prior abdominal infection (30.7% vs. 19.8%; p = .029). Using a Kaplan-Meier analysis, there was not a significant difference in hernia recurrence between the two mesh types, with both types having Kaplan Meir 5-year recurrence-free survival rates of about 72%. CONCLUSION: Using Kaplan-Meier analysis, synthetic mesh and biosynthetic mesh result in comparable hernia recurrence rates and surgical site infection rates in abdominal wall reconstruction patients with follow-up to as long as five years.

Postoperative perineal hernia repair: what is the evidence?

The present study determined the characteristics of perineal hernia treatment in the literature, and the incidence of postoperative recurrence was stratified according to repair techniques. A systematic search of the available literature on the treatment of postoperative perineal hernias was performed using a major database. The types of repair techniques and outcome were entered into an electronic database and a pooled analysis was performed. A total of 213 cases of postoperative perineal hernia repair were collected from 20 relevant articles in the literature after excluding case reports (n < 3). Synthetic mesh was the material used most frequently for perineal hernia repair (55.9%). The most frequently used approach in perineal hernia repair was the perineal approach (56.5%). The recurrence rate was highest with the use of biological mesh (40.4%) and the perineal approach (35.6%). The recurrence rate was lowest in the combined abdominal & perineal approach (0%), followed by the abdominal approach (8.8%) and the laparoscopic approach (11.8%). A number of different repair techniques have been described in the literature. The use of synthetic mesh via a combined abdominal-perineal approach or intraabdominal/laparoscopic approach was shown to be associated with a reduced postoperative recurrence rate.

Synthetic mesh versus biological mesh to prevent incisional hernia after loop-ileostomy closure: a randomized feasibility trial.

BACKGROUND: Incisional hernia is a frequent complication after loop-ileostomy closure, rationalizing hernia prevention. Biological meshes have been widely used in contaminated surgical sites instead of synthetic meshes in fear of mesh related complications. However, previous studies on meshes does not support this practice. The aim of Preloop trial was to study the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. METHODS: The Preloop randomized, feasibility trial was conducted from April 2018 until November 2021 in four hospitals in Finland. The trial enrolled 102 patients with temporary loop-ileostomy after anterior resection for rectal cancer. The study patients were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene Macro™, Medtronic) (SM) or a biological mesh (Permacol™, Medtronic) (BM) to the retrorectus space at ileostomy closure. The primary end points were rate of surgical site infections (SSI) at 30-day follow-up and incisional hernia rate during 10 months' follow-up period. RESULTS: Of 102 patients randomized, 97 received the intended allocation. At 30-day follow-up, 94 (97%) patients were evaluated. In the SM group, 1/46 (2%) had SSI. Uneventful recovery was reported in 38/46 (86%) in SM group. In the BM group, 2/48 (4%) had SSI (p > 0.90) and in 43/48 (90%) uneventful recovery was reported. The mesh was removed from one patient in both groups (p > 0.90). CONCLUSIONS: Both a synthetic mesh and biological mesh were safe in terms of SSI after loop-ileostomy closure. Hernia prevention efficacy will be published after the study patients have completed the 10 months' follow-up.

"Hook Shape" Nipple-Sparing Mastectomy and Prepectoral Implant Reconstruction: Technique, Results and Outcomes from a Preliminary Case Series.

INTRODUCTION: Nipple-sparing mastectomy (NSM) is a surgical procedure increasingly performed for breast cancer or risk reduction surgeries. The site of skin incision seems to affect not only cosmesis but also technical ease in operating and vascular viability of the nipple. We present a series of patients who underwent a modified vertical surgical approach for NSM, which resulted to be safe, reliable, and with good esthetic results. MATERIALS AND METHODS: From December 2016 to February 2019, 27 "Hook Shape" incision NSMs were performed. All patients underwent an immediate subcutaneous muscle-sparing reconstruction with tissue expander covered by a titanium-coated polypropylene mesh, followed by a second surgical step with expander substitution and lipofilling on the definitive implant when indicated. Preoperative and postoperative BREAST-Q patient-reported outcomes measure was performed in all cases. RESULTS: Postoperative morbidity was evaluated: One patient developed seroma and another presented a systemic infection that resolved with intravenous infusion of antibiotics. One patient experienced vertical wound dehiscence, recovered after conservative treatment and without implant exposure. No implant loss was observed. Nipple-areola complex necrosis or ischemia rate was 0%. The BREAST-Q outcomes reported significant increases in the overall satisfaction with breast (p < 0.05), psychosocial well-being (p < 0.05), and sexual well-being (p < 0.05) sections. Scores in the physical impact of surgery section appeared to decline from preoperative to postoperative evaluations, with no statistically significant results. CONCLUSION: The mastectomy incision pattern can burden the surgical challenge, impact vascular viability of the nipple and significantly affect the aesthetic outcomes in breast reconstruction. We report our experience with an alternative approach for NSM, which appears a safe, practical, and reproducible method for patients with small- to medium-sized breasts and little/medium ptosis (grade I or II). LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Impact of a mid-urethral synthetic mesh sling on long-term risk of systemic conditions in women with stress urinary incontinence: a national cohort study.

OBJECTIVE: To compare the incidence of systemic conditions between women who had surgical treatment for stress incontinence with mesh and without mesh. DESIGN: National cohort study. SETTING: English National Health Service. POPULATION: Women with no previous record of systemic disease who had first-time urinary incontinence surgery between 1 January 2006 and 31 December 2013, followed up to the earliest of 10 years or 31 March 2019. METHODS: Competing-risks regression was used to estimate hazard ratios (HR), adjusted for patient characteristics, with HR > 1 indicating increased incidence following mesh surgery. MAIN OUTCOME MEASURES: First postoperative admission with a record of autoimmune disease, fibromyalgia or myalgic encephalomyelitis up to 10 years following the first incontinence procedure. RESULTS: The cohort included 88 947 women who had mesh surgery and 3389 women who had non-mesh surgery. Both treatment groups were similar with respect to age, socio-economic deprivation, comorbidity and ethnicity. The 10-year cumulative incidence of autoimmune disease, fibromyalgia or myalgic encephalomyelitis was 8.1% (95% CI 7.9-8.3%) in the mesh group and 9.0% (95% CI 8.0-10.1%) in the non-mesh group (adjusted HR 0.89, 95% CI 0.79-1.01; P = 0.07). A sensitivity analysis including only autoimmune diseases as an outcome returned a similar result. CONCLUSIONS: These findings do not support claims that synthetic mesh slings cause systemic disease. TWEETABLE ABSTRACT: No evidence of increased risk of systemic conditions after stress incontinence treatment with a mesh sling.

Long-term outcome of absorbable synthetic mesh in clean ventral hernia repairs.

BACKGROUND: There are many materials available for the reinforcement of complex abdominal wall reconstruction, including permanent synthetic, biologic, and absorbable synthetic meshes. The recurrence rate of complex hernia repairs beyond 5 years has not been reported. We hypothesized that the use of absorbable synthetic mesh in clean wounds would yield favorable long-term outcomes. STUDY DESIGN: Patients who underwent open complex ventral hernia repair with clean wounds (CDC class 1) using absorbable synthetic mesh (Bio-A, Gore, Flagstaff, AZ) in the retrorectus position were retrospectively reviewed. Chart review and a validated telephone questionnaire to screen for recurrence were utilized to evaluate and document hernia recurrence. RESULTS: A total of 49 patients were included in this study. Patients were followed for recurrences for up to 105 months, with a mean follow-up time of 62.4 months (5.2 years). The total number of midline hernia recurrence was 7 out of the original 49 patients (14%). The mean and median recurrence time are 37.4 and 38.8 months, respectively. Kaplan-Meier survival analysis estimated hernia recurrence rate as 2%, 4.6%, 7.1%, 12%, 15%, and 18% at 12, 24, 36, 48, 60, and 72 months, respectively. CONCLUSION: The use of absorbable synthetic mesh in clean wound ventral hernia repair resulted in favorable long-term recurrence rates. The recurrence rate of absorbable synthetic mesh is similar to that of permanent synthetic mesh, which gives a viable option for patients in whom permanent synthetic mesh is not an option.

Risk of reoperation 10 years after surgical treatment for stress urinary incontinence: a national population-based cohort study.

BACKGROUND: There is a debate about the safety and effectiveness of surgical treatments for stress urinary incontinence. Controversy about the use of synthetic mesh sling insertion has led to an increased uptake of retropubic colposuspension and autologous sling procedures. Comparative evidence on the long-term outcomes from these procedures is needed. OBJECTIVE: To compare the risk of reoperation at 10 years after operation between women treated for stress urinary incontinence with retropubic colposuspension, mesh sling insertion, and autologous sling procedures. STUDY DESIGN: The records of admissions to National Health Service hosptials were used to identify women who had first-time stress incontinence surgery between 2006 and 2013 in England. The first incidence of the following outcomes was assessed: further stress incontinence surgery, surgery for a complication (either mesh removal, prolapse repair, or incisional hernia repair), and any reoperation (either further stress incontinence surgery, mesh removal, prolapse repair, or incisional hernia repair). The cumulative incidence of each of these outcomes up to 10 years after surgery was calculated, considering death as a competing event. Multivariable modeling was then used to estimate the reoperation hazard ratios for the different initial surgery types with adjustments for patient characteristics and concurrent prolapse surgery or hysterectomy. RESULTS: The analysis included 2262 women treated with retropubic colposuspension, 92,524 treated with mesh sling insertion, and 1234 treated with autologous sling. The cumulative incidence of any first reoperation at 10 years was 21.3% (95% confidence interval, 19.5-23.0) after retropubic colposuspension, 10.9% (10.7-11.1) after mesh sling insertion, and 12.0% (10.2-13.9) after autologous sling procedures. The women who had a retropubic colposuspension were significantly more likely to have a reoperation than women who had an autologous sling (adjusted hazard ratio for any reoperation: 1.79 [1.47-2.17]; for further stress incontinence surgery: 1.64 [1.19-2.26]; for surgery for complications: 1.89 [1.49-2.40]), whereas the women who had mesh slings had a similar hazard (for any reoperation: 0.90 [0.76-1.07]; for further stress incontinence surgery: 0.75 [0.57-0.99]; for surgery for complications: 1.11 [0.89-1.36]). A sensitivity analysis excluding the women who had concurrent prolapse surgery or hysterectomy produced similar results. CONCLUSION: Retropubic colposuspension is associated with higher risk of reoperation at 10 years after surgery than mesh sling insertion or autologous sling procedures, with 1 in 5 women requiring reoperation.

Closing Contaminated Fascial Defects With Synthetic Mesh and a Vacuum-Assisted Closure Device.

BACKGROUND: The use of synthetic mesh is considered too high risk, and therefore, not an option when closing a contaminated abdominal fascial defect. This study evaluated the clinical outcomes when using synthetic mesh combined with vacuum-assisted closure (VAC) dressing to close these facial defects. MATERIALS AND METHODS: From 2010 to 2016, a retrospective review was performed, including 34 patients in a single rural trauma center who underwent a damage control laparotomy in the presence of a contaminated or infected field. Definitive abdominal closure with a bridging polypropylene mesh along with the application of a VAC dressing was done in all cases. Data collection included baseline demographics, operative indication, postoperative complications, mortality and length of follow up. RESULTS: Median age of the patients was 67 y (IQR 40-87 y), with 22 (65%) being male at the time of operation. The median duration of clinical follow-up was 15.15 mo. The observed complications included three fistulas, two hernias, nine draining sinus tracts, and three mesh explanations with an overall complication rate of 41.1%. Although the absolute observed fistula rate was 8.8% (3 cases), the adjusted mesh-related fistulas formation rate after chart review was 0.0%. No mortalities were attributed directly to mesh-related complication. CONCLUSIONS: This study found no mesh-related fistulas when using a synthetic mesh along with a VAC dressing for abdominal closure in a contaminated field. These results may provide a platform for further study regarding the safety of this technique.

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.

A semi-Markov model comparing the lifetime cost-effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer.

AIM: Parastomal hernia (PSH) is a common problem following colostomy. Using prophylactic mesh during end colostomy creation may reduce PSH incidence, but concerns exist regarding the optimal type of mesh, potential long-term complications, and cost-effectiveness of its use. We evaluated the cost-effectiveness of mesh prophylaxis to prevent PSH in patients undergoing end colostomy creation for rectal cancer. METHODS: We developed a decision-analytical model, stratified by rectal cancer stages I-IV, to estimate the lifetime costs, quality-adjusted life-years (QALYs) and net monetary benefits (NMBs) of synthetic, biologic and no mesh from a UK NHS perspective. We pooled the mesh-related relative risks of PSH from 13 randomised controlled trials (RCTs) and superimposed these on the baseline (no mesh) risk from a population-based cohort. Uncertainty was assessed in sensitivity analyses. RESULTS: Synthetic mesh was less costly and more effective than biologic and no mesh to prevent PSH for all rectal cancer stages. At the willingness-to-pay threshold of £20,000/QALY, the incremental NMBs (95% CI) ranged between £1,706 (£1,692 to £1,720) (stage I) and £684 (£678 to £690) (stage IV) for synthetic versus no mesh, and £2,038 (£1,997 to £2,079) (stage I) and £1,671 (£1,653 to £1,689) (stage IV) for synthetic versus biologic mesh. Synthetic mesh was more cost-effective than no mesh unless the relative risk of PSH was ≥0.95 for stages I-III and ≥0.93 for stage IV. [Correction added on 05 October 2021 after first online publication: The estimation of health outcomes (QALYs) for all three interventions evaluated (synthetic mesh; biologic mesh; no mesh) have been corrected in this version.] CONCLUSIONS: Synthetic mesh was the most cost-effective strategy to prevent the formation of PSH in patients after end colostomy for any rectal cancer stage; however, conclusions are dependent on which subset of RCTs are considered to provide the most robust evidence.

A novel biosynthetic scaffold mesh reinforcement affords the lowest hernia recurrence in the highest-risk patients.

INTRODUCTION: Patients with higher postoperative infection risk undergoing ventral hernia repair (VHR) have limited options for mesh use. Biosynthetic mesh is intended to utilize the durability of synthetic mesh combined with the biocompatibility of biologic mesh. We sought to assess the outcomes of a novel biosynthetic scaffold mesh for VHR in higher risk patients over a 12-month postoperative period. METHODS: Two cohorts of 50 consecutive patients who underwent VHR with TELA Bio OviTex biosynthetic or synthetic mesh were retrospectively compared. Endpoints included surgical site occurrence (SSO), readmission rate, and hernia recurrence following VHR at 12 months postoperatively. RESULTS: OviTex mesh placement was associated with higher risk Ventral Hernia Working Group (VHWG) distribution and more contaminated CDC wound class distribution compared to synthetic mesh placement (VHWG grade 3: 68% vs. 6%, p < 0.001; CDC class > I: 70% vs. 6%, p < 0.001). Additionally, concomitant procedures were performed more often with OviTex mesh placement than synthetic mesh placement (70% vs 10%, p < 0.001). The OviTex mesh performed comparably to synthetic mesh in terms of incidences of SSO (36% vs 22%, p = 0.19), readmission rates (24% vs 14%, p = 0.31), and hernia recurrence (6% vs 12%, p = 0.74). On further evaluation, patients who developed SSO with OviTex mesh (n = 18) had a 17% hernia recurrence whereas those with synthetic mesh (n = 11) had an associated 55% hernia recurrence (p = 0.048). CONCLUSIONS: The OviTex biosynthetic mesh was used in higher risk patients and performed similarly to synthetic mesh in regards to rate of SSO, readmissions, and hernia recurrence. Furthermore, patients who developed SSO with Ovitex mesh were significantly less likely to have hernia recurrence than those with synthetic mesh. Overall, the data suggest that biosynthetic mesh is a more desirable option for definitive hernia repair in higher risk patients.

Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets.

INTRODUCTION AND HYPOTHESIS: Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. METHODS: Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. RESULTS: Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). CONCLUSIONS: Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

Preventing Peterson's space hernia using a BIO synthetic mesh.

BACKGROUND: Internal hernias occur after Roux-en-Y gastric bypass surgery (RYGB) when small bowel herniates into the intermesenteric spaces that have been created. The closure technique used is related to the internal hernia risks outcomes. Using a non-resorbable double layered suture, this risk can be significantly reduced from 8.9 to 2.5% in the first three postoperative years. By closing over a BIO mesh, the risk might be reduced even more. SETTING: Two large private hospitals specialized in bariatric surgery. METHODS: All patients receiving a RYGB for (morbid) obesity between 2014 and 2018 were included in this retrospective study. In all patients, the entero-enterostomy (EE) was closed using a double layered non-absorbable suture. In 2014, Peterson's space was closed exclusively using glue, the years hereafter in a similar fashion as the EE, combined with a piece of glued BIO Mesh. RESULTS: The glued RYGB patients showed 25% of patients with an internal hernia (14%) or open Peterson's space compared to 0.5% of patients (p < 0.001) who had a combined sutured and BIO Mesh Closure of their Peterson's space defect. Although this was an ideal technique for Peterson's space, it led to 1% of entero-enterostomy kinking due to the firm adhesion formation. CONCLUSION: Gluing the intermesenteric spaces is not beneficial but placing a BIO Mesh in Peterson's space is a promising new technique to induce local adhesions. It is above all safe, effective and led to an almost complete reduction of Peterson's internal herniations. In the future, a randomized controlled trial comparing this technique to a double layered, non-absorbable suture should give more insights into which is the optimal closure technique.

Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).

OBJECTIVE: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. DESIGN: Randomised controlled trial. SETTING: Thirty-three UK hospitals. POPULATION: Women having surgery for recurrent prolapse. METHODS: Women recruited using remote randomisation. MAIN OUTCOME MEASURES: Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. RESULTS: A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. TWEETABLE ABSTRACT: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.

A systematic review of the management of synthetic mesh erosion of the rectum following urogynaecological surgery.

AIM: Synthetic rectal mesh erosion is a challenging complication following urogynaecological surgery. The aim of this study was to determine the optimal management of rectal mesh erosion following urogynaecological surgery. METHOD: A systematic review was undertaken following a pre-defined protocol registered with PROSPERO (CRD42018112425) in accordance with PRISMA guidelines. Searches of MEDLINE online database, Cochrane Library and clinical trial registries (ClinicalTrials.gov, EU Clinical Trials, ISRCTN registry) were performed. The included articles were heterogeneous - therefore a narrative synthesis was performed. RESULTS: Fourteen studies were included in the review: 11 case reports, one case series, one retrospective cohort and one prospective multicentre trial. Fourteen rectal mesh erosions were identified. Eight (57%) of the rectal erosions underwent major abdominal surgery. In two of these cases, the abdominal approach was used only after failure of the transanal route. Five (36%) of the mesh erosions were managed using a transanal approach. In one case, the mesh passed without intervention. CONCLUSION: Synthetic rectal mesh erosion can be managed successfully via either a transanal or a transabdominal approach with a partial or complete excision of the mesh. An examination under anaesthetic with an attempted transanal removal of mesh should be considered the first step in the management of this condition before consideration of more invasive surgery.