Project description:IntroductionVentral hernia repair is one of the most common surgeries performed in the United States. Failure of hernia repairs can be attributed to sutures pulling through tissue or mesh (anchor point failure). T-Line Hernia Mesh is the first mesh designed to specifically prevent anchor point failure by distributing tension. This case study of two patients is the first clinical application of the novel T-Line Hernia Mesh.Presentation of caseTwo separate patients presented with symptomatic ventral hernia secondary to previous laparotomy. Patient 1 is a fifty-five year-old male who underwent open ventral hernia repair with T-Line Hernia Mesh onlay placement. Patient 2 is a fifty-eight year-old female with a symptomatic ventral hernia that underwent bilateral component separation and primary hernia repair with T-Line Hernia Mesh. Both patients postoperative course was uneventful with no reported surgical site occurrences or hernia recurrence.DiscussionT-Line Hernia Mesh provides a new innovative approach to hernia surgery. This provides the first clinical outcomes. No complications were observed. In addition, this manuscript also demonstrates the surgical technique for the first time.ConclusionThis cases and technical description provides the initial report for a new designed T-Line Hernia Mesh that could result in a paradigm shift in hernia surgery concepts.
Project description:Background: The introduction of mesh for reinforcement of ventral hernia repair (VHR) led to a significant reduction in hernia recurrence rates. However, it remains controversial whether synthetic or biologic mesh leads to superior outcomes. Recently, hybrid mesh consisting of reinforced biosynthetic ovine rumen (RBOR) has been developed and aims to combine the advantages of biologic and synthetic mesh; however, outcomes after VHR with RBOR have not yet been compared with the standard of care. Methods: We performed a retrospective analysis on 109 patients, who underwent VHR with RBOR (n = 50) or synthetic polypropylene mesh (n = 59). Demographic characteristics, comorbidities, postoperative complications, and recurrence rates were analyzed and compared between the groups. Multivariate logistic regression models were fit to assess associations of mesh type with overall complications and surgical site occurrence (SSO). Results: Patients who underwent VHR with RBOR were older (mean age 63.7 versus 58.8 years, P = 0.02) and had a higher rate of renal disease (28.0 versus 10.2%, P = 0.01) compared with patients with synthetic mesh. Despite an unfavorable risk profile, patients with RBOR had lower rates of SSO (16.0 versus 30.5%, P = 0.12) and similar hernia recurrence rates (4.0 versus 6.78%, P = 0.68) compared with patients with synthetic mesh. The use of synthetic mesh was significantly associated with higher odds for overall complications (3.78, P < 0.05) and SSO (3.87, P < 0.05). Conclusion: Compared with synthetic polypropylene mesh, the use of RBOR for VHR mitigates SSO while maintaining low hernia recurrence rates at 30-month follow-up.
Project description:Background: Many surgeons utilize biologic mesh for elective complex ventral hernia repair (VHR; large hernias, contaminated fields, or patients with comorbid conditions). However, no randomized controlled trials (RCTs) have compared biologic and synthetic mesh. We hypothesize biologic mesh would result in fewer major complications at one-year post-operative compared with synthetic mesh. Patients and Methods: We performed a single-center, pilot RCT. All eligible patients undergoing complex, open VHR were randomly assigned to receive biologic or synthetic mesh placed in the retromuscular position. Primary outcome was major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative. Secondary outcomes included surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade. Outcomes were assessed using Fisher exact test and Bayesian generalized linear models. Results: Of 87 patients, 44 were randomly assigned to biologic mesh and 43 to synthetic mesh. Most cases were wound class 2-4 (68%) and 75% had a hernia width >4 cm. Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53%). Compared with patients in the synthetic mesh group, patients in the biologic mesh group had a higher percentage of: major complications at one-year post-operative (42.4% vs. 21.6%; relative risk [RR] = 1.96 [95% confidence interval {CI} = 0.94-4.08]; number needed to harm = 4.8; p = 0.071); SSI (15.9% vs. 9.3%; RR = 1.71 [95% CI = 0.54-5.42]; p = 0.362); wound dehiscence (25.0% vs. 14.0%; RR = 1.79 [95% CI = 0.73-4.41]; p = 0.205); and re-admissions (22.7% vs 9.3%; RR = 2.44 [95% CI = 0.83-7.20]; p = 0.105). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had a 95% probability of increased risk of major complications at one-year post-operative. No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. Conclusions: In elective complex open VHR, biologic mesh demonstrated no benefit compared with synthetic mesh in one-year outcomes. Moreover, Bayesian analysis suggests that biologic mesh may have an increased probability of major complications.
Project description:BackgroundNewer minimally invasive techniques have supplanted laparotomy and thoracotomy for management of hiatal hernias. Limited data exists on outcomes after robotic hiatal hernia repair without mesh despite the increasing popularity of this approach. We report our high-volume experience with durable robotic hiatal hernia repair with gastric fundoplication without mesh.MethodsA retrospective review was conducted on patients with type I-IV hiatal hernias who underwent an elective robotic-assisted repair from 2016 to 2019 using a novel technique of approximating the hiatus with running barbed absorbable (V-locTM) suture and securing it with interrupted silk sutures. Main outcomes included length of stay, readmission rate, and recurrence rate.ResultsA total of 144 patients were reviewed. The average age of the patient was 61 years. Most of the patients were female [95 females (66%) to 49 males], and the average body mass index (BMI) was 29.96 kg/m2. The average operating time was 173 minutes (standard deviation 62 minutes). The average length of stay in the hospital was 2 days, and 89% of patients went home within the first 3 days. Ten patients (6.9%) were readmitted within 30 days, there were no mortalities in 30 days, and there were 6 (4.2%) recurrences on follow up requiring reoperation.ConclusionsElective robotic hiatal hernia repair with fundoplication and primary closure of the hiatus with V-locTM and nonabsorbable suture without mesh is safe and effective. The robotic approach has similar operative times, lengths of stay, and complications compared to nationally published data on laparoscopic hiatal hernia repairs.
Project description:PurposeParastomal hernia is a common complication following a stoma and may cause leakage or incarceration. No optimal treatment has been established, and existing methods using mesh repair are associated with high recurrence rates and a considerable risk for short- and long-term complications including death. A double-layer intraperitoneal on-lay mesh (IPOM), the Parastomal Hernia Patch (BARD™), consisting of ePTFE and polypropylene, has been developed and tailored to avoid recurrence. To evaluate the safety of and recurrence rate using this mesh, a nonrandomised prospective multicentre study was performed.MethodFifty patients requiring surgery for parastomal hernia were enrolled. Clinical examination and CT scan prior to surgery were performed. All patients were operated on using the Parastomal Hernia Patch (BARD). Postoperative follow-up at one month and one year was scheduled to detect complications and hernia recurrence.ResultsThe postoperative complication rate at one month was 15/50 (30%). The parastomal hernia recurrence rate at one year was 11/50 (22%). The reoperation rate at one month was 7/50 (14%), and further 5/50 (10%) patients were reoperated on during the following eleven months.
Project description:Within the past decade, poly-4-hydroxybutyrate (P4HB) biosynthetic mesh has been introduced as a potential alternative to traditional biologic and synthetic mesh in ventral hernia repair (VHR). The aim of this study was to systematically assess clinical outcomes with the P4HB in VHR.MethodsA literature search identified all articles published in 2000 involving the use of P4HB in VHR. Descriptive statistics were used to synthesize collective data points, including postoperative outcomes. A pooled analysis of postoperative outcomes was performed using chi-square test and Fisher exact test.ResultsAcross 7 studies, the P4HB was used in 453 patients. The mean rate of surgical site infection (SSI) was 6.8% (31/453), reoperation 10.7% (30/281), and recurrence 9.1% (41/453). At an average follow-up of 26.8 months, the incidence of recurrence was 10.4% (28/270). Onlay was significantly associated with increased recurrence (14.2% versus 4.4%, P = 0.001). Among sublay placements, there was no difference in recurrence in clean (Center for Disease Control [CDC] 1) or contaminated (CDC >1) wounds (2.7% versus 6.1%, P = 0.585), but contaminated wounds were associated with increased SSI (2.7% versus 15.2%, P = 0.028). Ventral Hernia Working Group grade 2 and 3 did not have different incidences of recurrence (8.0% versus 5.1%, P = 0.526) nor SSI (5.1% versus 14.6%, P = 0.265).ConclusionsOverall, clinical outcomes of the P4HB mesh in VHR are acceptable. The P4HB mesh serves as a reliable alternative to traditional synthetic and biologic mesh across a range of defect characteristics and patient health conditions. Further research is needed to better understand the conditions in which it may provide a clinical benefit over traditional mesh types.
Project description:ObjectiveThe aim of this study was to compare the likelihood of bowel obstruction according to the placement of the mesh (either intraperitoneal or extraperitoneal) in ventral hernia repairs.Materials and methodsPatients were divided into two groups, an intraperitoneal (IP) group (mesh placed by laparoscopy or with an open approach) and an extraperitoneal (EP) group, all operated on in the Digestive Surgery Department at the Dijon University Hospital. The primary outcome was the occurrence of an episode of bowel obstruction requiring hospitalization and confirmed by abdominal CT scan.ResultsBetween March 2008 and July 2021, 318 patients were included, with 99 patients in the EP group (71 meshes placed preperitoneally and 28 placed retromuscularly) and 219 patients in the IP group (175 patients operated on laparoscopically versus 44 patients by direct approach). Three patients presented an episode of acute intestinal obstruction, with no difference between the two groups (p = 0.245), although all bowel obstructions occurred in the IP group and with the laparoscopic approach (1.7% of patients operated on by laparoscopy). The occlusive events occurred at 1 month, 2 years, and 3 years. There was no difference in terms of recurrence or postoperative chronic pain. There were more seroma and mesh infections in the EP group (p < 0.05). Two patients operated on by laparoscopy had undetected bowel injuries, prompting emergent surgery for peritonitis.ConclusionsNo statistically significant difference was found in terms of bowel obstruction between the intraperitoneal and the extraperitoneal position, but all cases of obstruction happened in the intraperitoneal mesh group. Visceral lesions remain a major complication of the laparoscopic approach that should not be neglected.
Project description:ImportanceAlthough multiple versions of polypropylene mesh devices are currently available on the market for hernia repair, few comparisons exist to guide surgeons as to which device may be preferable for certain indications. Mesh density is believed to impact patient outcomes, including rates of chronic pain and perception of mesh in the abdominal wall.ObjectiveTo examine whether medium-weight polypropylene is associated with less pain at 1 year compared with heavy-weight mesh.Design, setting, and participantsThis multicenter randomized clinical trial was performed from March 14, 2017, to April 17, 2019, with 1-year follow-up. Patients undergoing clean, open ventral hernia repairs with a width 20 cm or less were studied. Patients were blinded to the intervention.InterventionsPatients were randomized to receive medium-weight or heavy-weight polypropylene mesh during open ventral hernia repair.Main outcomes and measuresThe primary outcome was pain measured with the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a. Secondary outcomes included quality of life and pain measured at 30 days, quality of life measured at 1 year, 30-day postoperative morbidity, and 1-year hernia recurrence.ResultsA total of 350 patients participated in the study, with 173 randomized to receive heavy-weight polypropylene mesh (84 [48.6%] female; mean [SD] age, 59.2 [11.4] years) and 177 randomized to receive medium-weight polypropylene mesh (91 [51.4%] female; mean [SD] age, 59.3 [11.4] years). No significant differences were found in demographic characteristics (mean [SD] body mass index of 32.0 [5.4] in both groups [calculated as weight in kilograms divided by height in meters squared] and American Society of Anesthesiologists classes of 2-4 in both groups), comorbidities (122 [70.5%] vs 93 [52.5%] with hypertension, 44 [25.4%] vs 43 [24.3%] with diabetes, 17 [9.8%] vs 12 [6.8%] with chronic obstructive pulmonary disease), or operative characteristics (modified hernia grade of 2 in 130 [75.1] vs 140 [79.1] in the heavy-weight vs medium-weight mesh groups). Pain scores for patients in the heavy-weight vs medium-weight mesh groups at 30 days (46.3 vs 46.3, P = .89) and 1 year (30.7 vs 30.7, P = .59) were identical. No significant differences in quality of life (median [interquartile range] hernia-specific quality of life score at 1 year of 90.0 [67.9-96.7] vs 86.7 [65.0-93.3]; median [interquartile range] hernia-specific quality of life score at 30 days, 45.0 [24.6-73.8] vs 43.3 [28.3-65.0]) were found for the heavy-weight mesh vs medium-weight mesh groups. Composite 1-year recurrence rates for patients in the heavy-weight vs medium-weight polypropylene groups were similar (8% vs 7%, P = .79).Conclusions and relevanceMedium-weight polypropylene did not demonstrate any patient-perceived or clinical benefit over heavy-weight polypropylene after open retromuscular ventral hernia repair. Long-term follow-up of these comparable groups will elucidate any potential differences in durability that have yet to be identified.Trial registrationClinicalTrials.gov Identifier: NCT03082391.
Project description:BackgroundMany patients develop seroma after laparoscopic ventral hernia repair. It was hypothesized that leaving the hernial sac in situ may cause this complication.MethodsIn this patient- and outcome assessor-blinded, parallel-design single-centre trial, patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair were randomized (1 : 1) to either conventional fascial closure or peritoneal bridging. The primary endpoint was the incidence of seroma 12 months after index surgery detected by CT, evaluated in an intention-to-treat analysis.ResultsBetween September 2017 and May 2018, 62 patients were assessed for eligibility, of whom 25 were randomized to conventional closure and 25 to peritoneal bridging. At 3 months, one patient was lost to follow-up in the conventional and peritoneal bridging groups respectively. No seroma was detected at 6 or 12 months in either group. The prevalence of clinical seroma was four of 25 (16 (95 per cent c.i. 2 to 30) per cent) versus none of 25 patients in the conventional fascial closure and peritoneal bridging groups respectively at 1 month after surgery (P = 0·110), and two of 24 (8 (0 to 19) per cent) versus none of 25 at 3 months (P = 0·235). There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.ConclusionConventional fascial closure and peritoneal bridging did not differ with regard to seroma formation after laparoscopic ventral hernia repair.Trial registrationClinicalTrials.gov (NCT03344575).