Open Intraperitoneal Onlay Mesh Research Articles

Open intraperitoneal onlay mesh repair with anterior component separation as a bail-out procedure in the management of complex hernias.

Surgical repair of complex abdominal wall hernias remains technically demanding and is widely recognized as a risk factor for unfavorable outcomes with high recurrence and morbidity rates. The objective is to assess short- and long-term complications after open intraperitoneal onlay mesh (IPOM) repair combined with bilateral anterior component separation (ACS) for large and difficult incisional hernias, alongside evaluating hernia recurrence rates. This retrospective analysis utilized data sourced from Hospital electronic health records and a prospective database at an academic tertiary referral center. Data collection was carried out from patients operated between January 2006 and December 2017. Eligible patients had complex incisional hernias measuring at least 10cm in their transverse diameter and had an open IPOM repair with bilateral ACS. In our study group of 45 patients, the 30-day surgical site occurrence (SSO) rate was high (37.8%), primarily consisting of superficial postoperative complications as seroma (17.8%) and wound dehiscence (6.7%). Among six patients (13.3%), wound complications escalated to chronic infected mesh-related problems, leading to complete mesh removal in four cases (8.9%) and partial mesh removal in two cases (4.4%). Regarding long-term complications, five patients (11.1%) developed enterocutaneous fistula. The recurrence rate was modest [5 out of 41 (12.2%)] over a median follow-up period of 99 months. Despite a high SSO rate, application of the open IPOM technique with ACS could serve as a valuable rescue option for managing large and complex hernias, with acceptable hernia recurrence rates at long-term follow-up.

Open IPOMs for medium/large incisional ventral hernia repairs in the French Hernia Registry: factors associated with their use and mesh-related outcomes.

The use of open intra-peritoneal onlay mesh repairs (O-IPOMs) for treating medium/large incisional ventral hernias has come into question due to the development of minimally invasive and sublay procedures. This study aimed to identify factors that are associated with the use of O-IPOMs in France. We analysed prospectively collected data from the French Hernia Registry on incisional ventral hernia repairs (IVHR) for hernias ≥ 4cm in width. We obtained data for 2261 IVHR (from 11/09/2011 to 30/03/2020): 733 O-IPOMs and 1,528 other techniques. We found that the O-IPOMs were performed on patients with more patient-related risk factors compared with the other techniques. Specifically, there was a higher proportion of patients with ASA III/IV (40.47% vs. 28.02%; p < 0.00001) and at least one patient-related risk factor (66.17% vs. 58.51%; p = 0.0005). Of the 733 O-IPOMs, 195 used Ventrio ST™ (VST), the most commonly used mesh for such IPOMs in our database; the other 538 O-IPOMs used other meshes (OM). The VST subgroup had a higher proportion of patients with ASA III/IV (52.58% vs. 36.07%; p < 0.0001) and on anticoagulants (26.04% vs. 18.41%; p = 0.0229) compared with the OM subgroup; they also had a lower recurrence rate after 2years (5.83% vs. 15.41%; p = 0.008). However, large (≥ 10cm) or lateral defects were more common in the OM subgroup, and their mesh/defect area ratio was lower. O-IPOMs were performed on patients with more comorbidities and/or complex incisional hernias compared with other techniques.

OC-123 COMPARISON OF COMPLICATION RATES BETWEEN INTRA- AND EXTRAPERITONEAL HERNIA REPAIRS

Abstract Aim With the emergence of new laparoscopic techniques, Intra-Peritoneal-Onlay-Mesh (IPOM) has fallen out of favor for repairing abdominal wall hernias due to reported complications, including adhesions and bowel injury, our aim is to compare complication rates in our center between intra- and extraperitoneal techniques. Material &amp; Methods A retrospective analysis was conducted on data from our certified hernia center from 2018 to 2021. All patients who underwent an umbilical, epigastric or incisional hernia-repair were included. The primary outcome measures were complications, including bowel injury and adhesions. Results A total of 188 patients underwent a hernia repair. 74 (39%) patients hat an umbilical hernia, 22 (12%) an epigastric hernia and 92 (49%) had an incisional hernia. Most patients (110–58%) were treated with laparoscopic IPOM, 14 (7,4%) of them underwent an open IPOM. 46 (25%) had hernias repaired with direct suture and the remaining patients were treated with other techniques, including open sublay and mini or less open sublay (MILOS). After an average follow-up of 36months, only two (1%) patients developed a mechanical ileus, one after laparoscopic and one after open IPOM surgery. Bowel lesions occurred in two (1%) patients who underwent open IPOM and direct suture hernia repairs. There was no difference in complications between the different surgical techniques. Conclusion Our study suggests that the different techniques for hernia repair have similar rates of complications. Further research is needed to determine the most effective and safe approach for hernia repair.

P-068 RESULTS OF THE OPEN INTRAPERITONEAL ONLAY MESH TECHNIQUE WITH A PREFORMED PATCH FOR PRIMARY VENTRAL HERNIA AND INCISIONAL HERNIA

Abstract Aim Primary ventral hernias and incisional hernias are frequent, but long–term results of their repair with a preformed patch are scarce. The aim was to evaluate the surgical results of the treatment of these hernias with the open intraperitoneal onlay mesh (open IPOM) technique, and to determine the needed follow–up for recurrence. Material and methods Observational retrospective single institution study of all consecutive patients intervened for ventral or incisional hernia with diameter inferior to 4 cm, from January 2013 to June 2020. The surgical repair was performed according to the open IPOM technique with a preformed patch and the defect was left unclosed. Relapsed hernias, those with a defect ≥ 4 cm, and lateral wall hernias were excluded. Results A total of 146 patients were intervened: 61.6% with umbilical hernias, 8.2% with epigastric hernias, 26.7% with trocar incisional hernias, and 3.4% with other incisional hernias. The global recurrence rate was 7.5% (11/146). Specifically, there it was 7.8% in umbilical hernias, 0% in epigastric hernias, 7.7% in trocar incisional hernias, and 20% (1/5) in other incisional hernias. The median time for recurrence was 14 months (IQR: 4,4–18,7). The median presential follow–up was 17,4 months (IQR: 6,5–27,3), and the median telematic follow-up was 36,9 months (IQR: 27,2–49,6). Conclusions The open IPOM technique with a preformed patch offers good results for the treatment of ventral and incisional hernias. A 2-year follow-up is still needed for the recurrence diagnosis. Note The preformed patch used was the Parietex™ Composite Ventral Patch (Medtronic, Minneapolis, MN, EEUU).

BJS-02 LONG-TERM REOPERATION RATE FOLLOWING PRIMARY VENTRAL HERNIA REPAIR: A REGISTER-BASED STUDY

Abstract Aim The aim of this study was to analyse the risk for reoperation following primary ventral hernia repair. Methods The study was based on umbilical hernia and epigastric hernia repairs registered in the population-based Swedish National Patient Register (NPR) 2010–2019. Reoperation was defined as repeat repair after primary repair. Results Altogether 30,253 umbilical hernia repairs and 7407 epigastric hernia repairs were identified. There were 624 reoperations registered following primary umbilical repair and 137 following primary epigastric repairs. In multivariable Cox proportional hazard analysis, the hazard ratio (HR) for reoperation was 0.284 (95% confidence interval (CI) 0.106–0.760) after open onlay mesh repair, 0.476 (CI 0.359–0.629) after open interstitial mesh repair, 0.368 (CI 0.230–0.590) after open sublay mesh repair, 0.446 (CI 0.167–1.194) after open intraperitoneal onlay mesh repair, 0.931 (CI 0.639–1.357) after laparoscopic repair, and 0.939 (CI 0.502–1.757) after other (unknown) techniques, when compared to open suture repair as reference method. Following umbilical hernia repair, the risk for reoperation was also significantly higher for patients aged ≤49 years (HR 1.669, CI 1.391–2.002), for women (HR 1.390, CI 1.178–1.641), and for patients with liver cirrhosis (HR 2.546, CI 1.050–6.174). For patients undergoing epigastric hernia repair, the only significant risk factor for reoperation was age ≤49 years (HR 2.079, CI 1.380–3.134). Conclusions All types of open mesh repair were associated with lower reoperation rates than open suture repair and laparoscopic repair. Female sex, young age and liver cirrhosis were risk factors for reoperation due to hernia recurrence, regardless of method.

Open versus laparoscopic intraperitoneal on-lay mesh repair: A comparison of outcomes in small ventral hernia

PurposeThe ideal surgical treatment of small ventral hernias (defect less than 4 cm) is still debatable. In our study, we sought to compare the outcomes of open versus laparoscopic intraperitoneal on-lay mesh (IPOM) repair in small ventral hernias. MethodsPatients with a single ventral hernia defect of less than 4 cm undergoing surgical mesh repair between January 2016 and September 2018 were prospectively registered for this study. The minimum follow-up duration was 12 months. Patient demographics, operative findings and regular post-operative follow-up details including recurrence rates and complications were recorded and analysed. Results41 patients underwent laparoscopic IPOM repair and 47 patients underwent open IPOM repair. The mean age for both groups is similar with no significant difference. The mean hernia defect size for the laparoscopic group is 2.8 cm (±0.8) whereas the mean hernia defect size for the open repair group is 2.1 cm (±0.4). The mean surgery duration for open IPOM repair was significantly shorter (59 min (±17) vs 74 min (±26); p = 0.001). There was no significant difference in the incidence of seroma formation and surgical site infections post-operatively. There was also no significant difference in both groups in terms of chronic pain and recurrence at 1-year follow-up. ConclusionOpen IPOM repair for small ventral hernias may be superior to laparoscopic IPOM repair due to the shorter operative duration, single incision, and no additional risk of port-site hernias. There was no difference in chronic pain, wound infection and recurrence rate between the two groups.

Long-term reoperation rate following primary ventral hernia repair: a register-based study

BackgroundThe aim of this study was to analyse the risk for reoperation following primary ventral hernia repair.MethodsThe study was based on umbilical hernia and epigastric hernia repairs registered in the population-based Swedish National Patient Register (NPR) 2010–2019. Reoperation was defined as repeat repair after primary repair.ResultsAltogether 29,360 umbilical hernia repairs and 6514 epigastric hernia repairs were identified. There were 624 reoperations registered following primary umbilical repair and 137 following primary epigastric repairs. In multivariable Cox proportional hazard analysis, the hazard ratio (HR) for reoperation was 0.292 (95% confidence interval (CI) 0.109–0.782) after open onlay mesh repair, 0.484 (CI 0.366–0.641) after open interstitial mesh repair, 0.382 (CI 0.238–0.613) after open sublay mesh repair, 0.453 (CI 0.169–1.212) after open intraperitoneal onlay mesh repair, 1.004 (CI 0.688–1.464) after laparoscopic repair, and 0.940 (CI 0.502–1.759) after other techniques, when compared to open suture repair as reference method. Following umbilical hernia repair, the risk for reoperation was also significantly higher for patients aged < 50 years (HR 1.669, CI 1.389–2.005), for women (HR 1.401, CI 1.186–1.655), and for patients with liver cirrhosis (HR 2.544, CI 1.049–6.170). For patients undergoing epigastric hernia repair, the only significant risk factor for reoperation was age < 50 years (HR 2.046, CI 1.337–3.130).ConclusionsAll types of open mesh repair were associated with lower reoperation rates than open suture repair and laparoscopic repair. Female sex, young age and liver cirrhosis were risk factors for reoperation due to hernia recurrence, regardless of method.

Is it safe to combine ventral hernia repair with bariatric surgery?

Obesity is one of the important precipitating factors for primary and incisional ventral hernias. There is controversy regarding the optimal time and method of repair of abdominal wall hernias in patients undergoing bariatric surgery. We reviewed our series of 250 patients who underwent bariatric surgery over 6 years period. 7 morbidly obese patients undergoing bariatric surgery had simultaneous ventral hernia repair. Roux-en-Y gastric bypass (RYGB) in 2 patients and laparoscopic sleeve gastrectomy (LSG) were done in 5 patients. 6 patients had primary midline paraumbilical hernia and 1 patient had large recurrent incisional hernia. Open intraperitoneal onlay mesh (IPOM) repair was done in 5 cases with hernia defect &lt;5 cm. Sutured repair was done in 1 patient, recurrence occurred after 3 months. IPOM repair was done 6 months later after significant weight loss. 1 patient of large incisional hernia (10 cm defect) with cholelithiasis underwent open mesh hernioplasty and panniculectomy. Postoperative seroma occurred in one patient, it subsided after repeated aspirations. After average follow up of over 2 years there has been no recurrence.

Comparison of the Intensity of Postoperative Pain Between Open and Laparoscopic Access of Ventral Hernioplasty with IPOM (Intraperitoneal Onlay Mesh) Technique

Introduction: Despite the numerous advantages of laparoscopic ventral hernioplasty over the open access hernioplasty, described in the literature, the general clinical experience is that patients have severe pain in the first few days, hence early postoperative pain is a challenge in this procedure.The aim of this study was to compare early postoperative pain and whether there was statistically significant difference in the intensity of postoperative pain among patients operated with open and laparoscopic approach with IPOM hernioplasty during resting and activity. Material and methods: A randomized, prospective, comparative study was performed on 63 patients who met the inclusion criteria, operated with the IPOM technique and divided into two groups: open access in 32 patients and laparoscopic approach in 31 patients. In both groups, postoperative pain was compared at eight time intervals during rest and activity, quantified using VAS. The statistical processing and analysis of the data was done in the statistical programme SPSS version 23.0. Results: The results of the study showed that at rest and activity, patients in both groups had significantly different pain intensities on the day of the intervention, the first and second day after the intervention (p&lt;0.0001). At these time points, the intensity of pain was significantly stronger in patients undergoing laparosopic hernioplasty. On the third and seventh postoperative days, as well as one and six months after the intervention, there was no significant difference in pain intensity between the two methods during rest and activity. Discussion: The general clinical experience confirmed in our study is that patients after laparoscopic ventral hernioplasty suffer from severe pain in the early postoperative period and it is the biggest challenge and problem after these operations. The explanation is that it is the result of transfascial sutures for mesh fixation in both groups and additionally multiple lesions of the parietal peritoneum in the laparoscopic method due to the numerous fixations of the mesh with tackers. Future research should focus on developing new non-traumatic methods for mesh fixation (Fibrin Glue) and studies that will analyse in detail the impact of postoperative pain on quality of life. Keywords: Laparoscopic IPOM technique, open IPOM technique, absorbable tackers, transfascial sutures, postoperative pain. DOI: 10.7176/JHMN/80-08 Publication date: September 30 th 2020

What is the outcome of the open IPOM versus sublay technique in the treatment of larger incisional hernias?: A propensity score-matched comparison of 9091 patients from the Herniamed Registry

IntroductionIn an Expert Consensus guided by systematic review, the panel agreed that for open elective incisional hernia repair, sublay mesh location is preferred, but open intraperitoneal onlay mesh (IPOM) may be useful in certain settings. This analysis of data from the Herniamed Registry aimed to compare the outcomes of open IPOM and sublay technique.MethodsPropensity score matching of 9091 patients with elective incisional hernia repair and with defect width ≥ 4 cm was performed. The following matching variables were selected: age, gender, risk factors, ASA score, preoperative pain, defect size, and defect localization.ResultsFor the 1977 patients with open IPOM repair and 7114 patients with sublay repair, n = 1938 (98%) pairs were formed. No differences were seen between the two groups with regard to the intraoperative, postoperative and general complications, complication-related reoperations and recurrences. But significant disadvantages were identified for the open IPOM repair in respect of pain on exertion (17.1% vs. 13.7%; p = 0.007), pain at rest (10.4% vs. 8.3%; p = 0.040) and chronic pain requiring treatment (8.8% vs. 5.8%; p < 0.001), in addition to rates of 3.8%, 1.1% and 1.1%, respectively, occurring in both matched patients. No relationship with tacker mesh fixation was identified. There are only very few reports in the literature with comparable findings.ConclusionCompared with sublay repair, open IPOM repair appears to pose a higher risk of chronic pain. This finding concords with the Expert Consensus recommending that incisional hernia should preferably be repaired using the sublay technique.

Laparoscopic Abdominal Wall Hernia Repair.

Background and Objectives:The aim of this retrospective monocentric study was to evaluate results and recurrence rate with long-term follow-up after laparoscopic incisional/ventral hernia repair.Methods:This was a retrospective, single-center, observational trial, collecting data from patients who underwent laparoscopic incisional/ventral abdominal hernia repair using the open intraperitoneal onlay mesh technique and a single mesh type. All patients signed an informed consent form before surgery.Results:A total of 1,029 patients were included. The median surgery time was 40 min (range 30–55) and the median length of hospital stay was 2 d (range 2–3). Intraoperative complications occurred in two of 1,029 patients (0.19%), whereas early postoperative surgical complications (within 30 d) occurred in 50 patients (4.86%). Postoperative complications according to Clavien-Dindo classification were as follows: I, 3.30% (34 of 1,029); II, 0.97% (10 of 1,029); IIIB, 0.58% (six of 1,029); IV, 0.00% (none of 1,029); and V, 0.00% (none of 1,029). During follow-up, bulging mesh was diagnosed in 58 of 1,029 patients (5.6%), and hernia recurred in 40 of 1,029 patients (3.9%). A mesh overlap equal to or greater than 4 cm appeared to be a significant protective factor for hernia recurrence (P < .001); a mesh overlap equal or greater than 5 cm appeared to be a significant protective factor for bulging (P < .001), whereas the use of resorbable fixing devices was a significant risk factor for hernia recurrence (odds ratio, 111.53, P < .001, 95% confidence interval, 21.53–577.67).Conclusion:This study demonstrates that laparoscopic repair of ventral/incisional abdominal wall hernias is a safe, effective, and reproducible procedure. Identified risk factors for recurrence are an overlap of less than 4 cm and the use of resorbable fixation means.

Mesh fixation in open IPOM procedure with tackers or sutures? A randomized clinical trial with preliminary results.

In open intra-peritoneal onlay mesh (IPOM) hernia repair, mesh fixation can be done by tacks, sutures or fibrin glue. There are randomized controlled trials (RCTs) on laparoscopic IPOM procedure, but no RCT so far has examined mesh fixation techniques in open IPOM repair. In a single-center RCT, 48 patients undergoing open IPOM repair of an abdominal wall hernia were included. After randomization, surgery was performed in a standardized fashion. Hernia size, extent of mesh fixation, and duration of surgery were documented. The primary endpoint was postoperative pain intensity. Secondary endpoints were: complications, length of stay, quality of life, return to work, hernia recurrence. Follow-up was 1year in all 48 patients. After using tacks, mean pain intensity was 16.9, which is slightly lower than after suture fixation (19.6, p = 0.20). The duration of surgery was about the same (83 vs. 85min). When using tack fixation, significantly more fixation points were applied as compared to sutures (19 vs. 12; p = 0.02), although mesh size was similar. The complication rate was similar (tacks: 6/28 vs. sutures: 3/20). Cost of suture fixation was about 26 €, which is markedly lower than the 180 € associated with tacks. However, surgeons clearly preferred mesh fixation with tacks, because it is more comfortable especially in small hernias. The present study failed to show an advantage of tacks over suture fixation and even there are more severe adverse events. Using tacks significantly increases the costs of hernia repair.

Open Intraperitoneal Onlay Mesh (IPOM) Technique for Incisional Hernia Repair.

In an Expert Consensus Guided by Systematic Review the panel agreed that for open elective incisional hernia repair sublay mesh location is preferred, but open intraperitoneal onlay mesh (IPOM) may be useful in certain settings. Accordingly, the available literature on the open IPOM technique was searched and evaluated.Material and Methods: A systematic search of the available literature was performed in July 2018 using Medline, PubMed, and the Cochrane Library. Forty-five publications were identified as relevant for the key question.Results: Compared to laparoscopic IPOM, the open IPOM technique was associated with significantly higher postoperative complication rates and recurrence rates. For the open IPOM with a bridging situation the postoperative complication rate ranges between 3.3 and 72.0% with a mean value of 20.4% demonstrating high variance, as did the recurrence rate of between 0 and 61.0% with a mean value of 12.6%. Only on evaluation of the upward-deviating maximum values and registry data is a trend toward better outcomes for the sublay technique demonstrated. Through the use of a wide mesh overlap, avoidance of dissection in the abdominal wall and defect closure it appears possible to achieve better outcomes for the open IPOM technique.Conclusion: Compared to the laparoscopic technique, open IPOM is associated with significantly poorer outcomes. For the sublay technique the outcomes are quite similar and only tendentially worse. Further studies using an optimized open IPOM technique are urgently needed.

Long-term results of laparoscopic versus open intraperitoneal onlay mesh incisional hernia repair: a propensity score-matched analysis

BackgroundIntraperitoneal onlay mesh repair (IPOM) of incisional hernia is performed by laparoscopic and open access. The aim of the present study is to compare open versus laparoscopic surgery specifically using an IPOM technique for incisional hernia repair.MethodsA propensity score-matched observational single center study of patients that underwent IPOM between 2004 and 2015 was conducted. The primary outcome was hernia recurrence; secondary outcomes include length of stay, surgical site infections (SSI), complications, and localization of recurrence.ResultsAmong 553 patients with incisional hernia repair, 59% underwent laparoscopic and 41% open IPOM. A total of 184 patients completed follow-up. After a mean follow-up of 5.5 years recurrence rate was 20% in laparoscopic and 19% in open repair (p = 1.000). Patients undergoing laparoscopic IPOM had significantly reduced operation time (median 120 vs. 180 min, p < 0.001), shorter hospital stays (6 vs. 8 days, p = 0.002), less complications (10 vs. 23%, p = 0.046), and fewer SSI (1 vs. 21%, p < 0.001).ConclusionsLaparoscopic IPOM is associated with reduced morbidity compared to open IPOM for incisional hernia repair.

A short term analysis of surgical management of umbilical and paraumbilical hernia

Umbilical hernia and paraumbilical hernia are ventral herniae that occur in infants and adults. According to current evidence, mesh repair is the treatment of choice to avoid recurrence. The aim of this study is to analyze the surgical methods, the types of meshes used, and their benefits. A retrospective analysis of patients diagnosed with umbilical hernia and paraumbilical hernia was performed. The patients' consent was obtained retrospectively. The various surgical techniques and different meshes used were analyzed. Forty-three patients were selected for the study. Of these, 23 patients underwent open mesh repair, 12 patients underwent laparoscopic intraperitoneal onlay mesh repair repair, and eight patients underwent open intraperitoneal onlay mesh repair repair. The duration of the surgery, mesh used, number of days of hospital stay, type of anesthesia, and postoperative complications were analyzed. Of the 43 patients, the patients who underwent open intraperitoneal onlay mesh repair had shorter postoperative hospital stays compared to other methods (median=1 day; range=1 to 2 days). The duration of surgery was longer for laparoscopic intraperitoneal onlay mesh repair and open mesh repair compared to the open intraperitoneal onlay mesh repair technique (p<0.05). The open intraperitoneal onlay mesh repair technique had advantages over the other methods for small-defect umbilical hernia and paraumbilical hernia. The duration of surgery was long for laparoscopic intraperitoneal onlay mesh repair compared to open mesh repair and the open intraperitoneal onlay mesh repair technique. Postoperative complications were insignificant for all three methods. Another advantage of the open intraperitoneal onlay mesh repair technique was a shorter postoperative hospital stay.

Preclinical evaluation of the effect of the combined use of the Ethicon Securestrap® Open Absorbable Strap Fixation Device and Ethicon Physiomesh™ Open Flexible Composite Mesh Device on surgeon stress during ventral hernia repair.

AimTo evaluate whether performing ventral hernia repairs using the Ethicon Physiomesh™ Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap® Open Absorbable Strap Fixation Device reduces surgical time and surgeon stress levels, compared with traditional surgical repair methods.MethodsTo repair a simulated ventral incisional hernia, two surgeries were performed by eight experienced surgeons using a live porcine model. One procedure involved traditional suture methods and a flat mesh, and the other procedure involved a mechanical fixation device and a skirted flexible composite mesh. A Surgery Task Load Index questionnaire was administered before and after the procedure to establish the surgeons’ perceived stress levels, and saliva samples were collected before, during, and after the surgical procedures to assess the biologically expressed stress (cortisol and salivary alpha amylase) levels.ResultsFor mechanical fixation using the Ethicon Physiomesh Open Flexible Composite Mesh Device in conjunction with the Ethicon Securestrap Open Absorbable Strap Fixation Device, surgeons reported a 46.2% reduction in perceived workload stress. There was also a lower physiological reactivity to the intraoperative experience and the total surgical procedure time was reduced by 60.3%.ConclusionsThis study provides preliminary findings suggesting that the combined use of a mechanical fixation device and a skirted flexible composite mesh in an open intraperitoneal onlay mesh repair has the potential to reduce surgeon stress. Additional studies are needed to determine whether a reduction in stress is observed in a clinical setting and, if so, confirm that this results in improved clinical outcomes.

PMD21 - An assessment of the Economic impact of the adoption of a new Mechanical fixation device along with a new skirted intra-peritoneal onlay mesh (IPOM) on Hospital costs of open Ventral Hernia repair Surgeries

PMD21 An AssessMent of the econoMic iMPAct of the ADoPtion of A new MechAnicAl fixAtion Device Along with A new skirteD intrAPeritoneAl onlAy Mesh (iPoM) on hosPitAl costs of oPen ventrAl herniA rePAir surgeries Panish J.M.1, Chekan E.2, Roy S.1 1Ethicon, Somerville, NJ, USA, 2Johnson & Johsnon (Ethicon), Cincinnati, OH, USA Objectives: Demonstrating economic value of new products is important for hospitals adoption. The combination of two devices: ETHICON SECURESTRAP® Open Absorbable Strap Fixation Device and ETHICON PHYSIOMESHTM Open Flexible Composite Mesh Device, offers a standardized approach to open IPOM repair of ventral hernia. This analysis assesses the potential economic value of using these devices when compared with other meshes and a hand-sutured fixation approach. MethOds: An economic model was developed to evaluate the budget impact to hospitals adopting ETHICON SECURESTRAPTM Open Fixation Device with ETHICON PHYSIOMESHTM Open in ventral hernia repair. A 1to 3-year time horizon was included in the Excel-based model. An increasing utilization rate for ETHICON SECURESTRAPTM Open (20% 60%), and ETHICON PHYSIOMESHTM Open (10% 30%) was assumed over 3-year horizon. Costs of the mechanical fixation device, suture supplies, mesh, OR time, anesthesia time, and potentially avoided surgical site infections were considered. The differences in total costs were calculated. Results: Based on the model inputs, a 3-year total potential saving of $240,650 was estimated for 100 annual open ventral hernia surgeries using ETHICON SECURESTRAPTM Open Fixation Device versus suture of various meshes. Over three years, although the use of ETHICON SECURESTRAPTM Open Fixation Device added $54,600 in supplies costs, this was completely offset by potential savings in OR time costs ($167,520), potential reduction in avoided surgical site infection or seroma costs due to shorter operating room time ($126,903), and potential reduction in anesthesia costs ($17,189). Similarly, a savings of $40,108 was expected in the very first year. cOnclusiOns: This analysis represents the first economic evaluation of ETHICON SECURESTRAPTM Open Fixation Device with ETHICON PHYSIOMESHTM Open in open ventral hernia surgery. Adoption of the two devices would likely result in savings for hospitals, driven by shorter procedure time and related expected clinical benefits.

Time Savings and Surgery Task Load Reduction in Open Intraperitoneal Onlay Mesh Fixation Procedure.

Background. This study assessed the reduction in surgeon stress associated with savings in procedure time for mechanical fixation of an intraperitoneal onlay mesh (IPOM) compared to a traditional suture fixation in open ventral hernia repair. Study Design. Nine general surgeons performed 36 open IPOM fixation procedures in porcine model. Each surgeon conducted two mechanical (using ETHICON SECURESTRAPTM Open) and two suture fixation procedures. Fixation time was measured using a stopwatch, and related surgeon stress was assessed using the validated SURG-TLX questionnaire. T-tests were used to compare between-group differences, and a two-sided 95% confidence interval for the difference in stress levels was established using nonparametric methodology. Results. The mechanical fixation group demonstrated an 89.1% mean reduction in fixation time, as compared to the suture group (p < 0.00001). Surgeon stress scores measured using SURG-TLX were 55.5% lower in the mechanical compared to the suture fixation group (p < 0.001). Scores in five of the six sources of stress were significantly lower for mechanical fixation. Conclusions. Mechanical fixation with ETHICON SECURESTRAPTM Open demonstrated a significant reduction in fixation time and surgeon stress, which may translate into improved operating efficiency, improved performance, improved surgeon quality of life, and reduced overall costs of the procedure.

Lessons and challenges during a 5-year follow-up of 21 Composix Kugel implantations

From its introduction in 2000 until its US recall in December 2005, the Composix Kugel mesh was implanted in an estimated 350,000 patients worldwide. In our patients, minor postoperative complications were followed after a few years by more serious problems (persistent abdominal pain, infections, intestinal perforations). In this study, we take stock after a 5-year follow-up and issue a plea for improved product development strategies and the creation of hernia registries. Between 2003 and 2006, we implanted the Bard(®) Composix(®) Kugel(®) mesh in 21 patients (11 men, 10 women, mean age 63.2 ± 13.7 years) with incisional hernias using the open intraperitoneal onlay mesh technique. The mesh is made on one side of ePTFE and on the other of polypropylene and is expanded by a polyethylene (PET) memory recoil ring. The average follow-up was 45.5 months. All patients had at least one risk factor for hernia recurrence. Explanted prostheses were analyzed by scanning electron microscopy (SEM) and subjected to mechanical strength tests. During the postoperative course, six patients suffered a wound healing disorder. Ten patients complained of persistent abdominal wall pain and four experienced recurrence of the hernia. In one patient, the mesh had to be explanted due to chronic infection. In one patient, the PET memory recoil ring broke after 5 years of follow-up with consequent small bowel perforation. The PET memory recoil ring exhibited clear signs of degradation on SEM and unmistakable signs of material fatigue in a materials testing machine. Patients with recalled Composix Kugel meshes face a singular risk for complications that may occur even many years after implantation. The most serious complication is the breakage of its PET memory recoil ring. Since the recall of the Composix Kugel Mesh, we have discontinued its use. It is necessary that future complications are documented in a common post-market surveillance registry. Algorithms need to be developed and promoted to support affected patients and surgeons.

Comparison of three separate antiadhesive barriers for intraperitoneal onlay mesh hernia repair in an experimental model

Adhesion formation is a common adverse effect in intraperitoneal onlay mesh (IPOM) surgery. Different methods of adhesion prevention have been developed, including coated meshes and separate antiadhesive barriers (SABs). In this study one type of mesh was tested with different SABs, which were fixed to the sutured mesh using fibrin sealant. The primary aim was to compare adhesion prevention between different SABs. Secondary aims were the assessment of tissue integration and evaluation of SAB fixation with fibrin sealant. Thirty-two rats were randomized to one of three treatment groups (SurgiWrap, Prevadh and Seprafilm) or a control group (no SAB). Animals were operated on with an open IPOM technique (8 per group). One macroporous polypropylene mesh per animal (2 × 2 cm) was fixed with four non-absorbable sutures. An antiadhesive barrier of 2·5 × 2·5 cm was fixed with fibrin sealant. After 30 days, adhesion formation, tissue integration, seroma formation, inflammation and vascularization were evaluated macroscopically and by histology. Prevadh and Seprafilm groups showed a significant reduction in adhesion formation compared with the control group. Tissue integration of the mesh was reduced in these groups. Fibrin sealant fixed the SAB to the mesh securely in all groups. Prevadh and Seprafilm are potent materials for the reduction of adhesion formation. A potential relationship between effective adhesion prevention and impaired tissue integration of the implant was observed. Fibrin sealant proved an excellent agent for SAB fixation.