Dataset Information

Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair.

ABSTRACT:

Purpose

Approximately 348,000 ventral hernia repairs are performed annually in the United States and the incisional hernia recurrence rate is approximately 20% as a result of suture and mesh device failure. Device failure is related to changes at the suture/tissue interface that leads to acute or chronic suture pull-through and surgical failure. To better manage mechanical tension, we propose a modified mesh design with extensions and demonstrate its mechanical superiority.

Methods

Comparative uniaxial static tensile testing was conducted on polypropylene suture and a modified mesh. Subsequently, a standard of care (SOC) mesh and modified mesh were evaluated using a tensometer in an acute hernia bench-top model.

Results

Modified mesh breaking strength, extension knot breaking strength, extension disruption, and extension anchoring were superior to suture (p < .05). Modified mesh ultimate tensile strength of anchoring was superior to SOC mesh (p < .05). Various stitch patterns and modifications in device design significantly improved device tension-free performance far beyond clinically relevant benchmarks (p < .05).

Conclusions

Testing demonstrates that the modified mesh outperforms SOC mesh and suture in all tested failure modes. SOC hernia mesh tears through tissue at stress levels below maximum physiologic stress, whereas, the modified hernia mesh is up to 200% stronger than SOC mesh at resisting suture tearing through tissue and maintains anchoring at stresses far beyond clinically relevant benchmarks. Modifying hernia mesh design significantly improves device mechanical performance and enhances tension-free repair.

SUBMITTER: Ibrahim MM

PROVIDER: S-EPMC5878138 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Publications

Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair.

Ibrahim Mohamed M MM Poveromo Luke P LP Glisson Richard R RR Cornejo Agustin A Farjat Alfredo E AE Gall Ken K Levinson Howard H

Journal of biomechanics 20180202

<h4>Purpose</h4>Approximately 348,000 ventral hernia repairs are performed annually in the United States and the incisional hernia recurrence rate is approximately 20% as a result of suture and mesh device failure. Device failure is related to changes at the suture/tissue interface that leads to acute or chronic suture pull-through and surgical failure. To better manage mechanical tension, we propose a modified mesh design with extensions and demonstrate its mechanical superiority.<h4>Methods</h ...[more]

PMID: 29426630

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Project description:ImportanceAntireflux surgery is an effective treatment of gastroesophageal reflux disease (GERD), but the durability of concomitant hiatal hernia repair remains challenging. Previous research reported that the use of a mesh-reinforced, tension-free technique was associated with more dysphagia for solid foods after 3 years without reducing hiatal hernia recurrence rates compared with crural sutures alone, but the long-term effects of this technique have not been assessed.ObjectiveTo assess the long-term anatomical and functional outcomes of using a mesh for hiatal hernia repair in patients with GERD.Design, setting, and participantsA double-blind, randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from January 11, 2006, to December 1, 2010. A total of 159 patients were recruited and randomly assigned. Data for the current analysis were collected from September 1, 2021, to March 31, 2022. All analyses were conducted with the intention-to-treat population.InterventionsClosure of the diaphragmatic hiatus with crural sutures alone vs a tension-free technique using a nonabsorbable polytetrafluoroethylene mesh (Bard CruraSoft).Main outcomes and measuresThe primary outcome was radiologically verified recurrent hiatal hernia after more than 10 years. Secondary outcomes were dysphagia scores (ranging from 1 to 4, with 1 indicating no episodes of dysphagia and 4 indicating more than 3 episodes of dysphagia per day) for solid and liquid foods, generic 36-Item Short Form Health Survey and disease-specific Gastrointestinal Symptom Rating Scale symptom assessment scores, proton pump inhibitor consumption, and reoperation rates. Intergroup comparisons of parametric data were performed using t tests; for nonparametric data, Mann-Whitney U, χ2, or Fisher exact tests were used. For intragroup comparisons vs the baseline at follow-up times, the Friedman test was used, and post hoc analysis was performed using Wilcoxon matched pairs.ResultsOf 145 available patients, follow-up data were obtained from 103 (response rate 71%; mean [SD] age at follow-up, 65 [11.3] years; 55 [53%] female), with 53 initially randomly assigned to mesh reinforcement, and 50 to crural suture alone. The mean (SD) follow-up time was 13 (1.1) years. The verified radiologic hiatal hernia recurrence rates were 11 of 29 (38%) in the mesh group vs 11 of 35 (31%) in the suture group (P = .61). However, 13 years postoperatively, mean (SD) dysphagia scores for solids remained significantly higher in the mesh group (mean [SD], 1.9 [0.7] vs 1.6 [0.9]; P = .01).Conclusions and relevanceFindings from this long-term follow-up of a randomized clinical trial suggest that tension-free crural repair with nonabsorbable mesh does not reduce the incidence of hiatal hernia recurrence 13 years postoperatively. This finding combined with maintained higher dysphagia scores does not support the routine use of tension-free polytetrafluoroethylene mesh closure in laparoscopic hiatal hernia repair for treatment of GERD.Trial registrationClinicalTrials.gov Identifier: NCT05069493.

Project description:BackgroundLaparoscopic revisional surgery for recurrent hiatal hernia (HH) is technically demanding. Re-recurrences are common and esophageal hiatus mesh reinforcement might improve durability of the repair, thus minimizing the risk of re-herniation.PurposeAssess safety and effectiveness of simple suture repair (no mesh group) vs. crural augmentation with a biosynthetic absorbable mesh (mesh group) in patients with recurrent HH.MethodsObservational retrospective study from September 2012 to December 2022. Only patients undergoing redo surgery for previous failures of hiatal hernia repair were enrolled. Surgical failure was defined as symptomatic recurrent HH with > 2 cm of gastric tissue above the diaphragmatic impression at upper gastrointestinal endoscopy and/or swallow study. Gastro-Esophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) and Short Form-36 (SF-36) questionnaires were used to assess and preoperative and postoperative symptoms and quality of life.ResultsOne hundred four patients were included. Overall, 60 patients (57.7%) underwent mesh-reinforced cruroplasty, whereas 44 (42.3%) underwent simple suture cruroplasty. Mesh and no mesh groups had similar baseline demographics, symptoms, prevalence of esophagitis and Barrett's esophagus, and HH size. A composite crural repair was most commonly performed in the mesh group (38.3% vs. 20.5%; p = 0.07). In addition to cruroplasty, most patients (91%) underwent a Toupet fundoplication. The 90-day postoperative complication rate was 8.6%, and there was no mortality. Recurrent HH was diagnosed in 21 patients (20.2%) with a clinical trend toward reduced incidence in the mesh group (16.7% vs. 25%; p = 0.06). Compared to baseline, there was a statistically significant improvement of median GERD-HRQL score (p < 0.01) and all SF-36 items (p < 0.01).ConclusionsLaparoscopic revisional surgery for recurrent HH is safe and effective. Selective use of biosynthetic mesh may protect from early recurrence and has the potential to reduce re-herniation in the long-term.

Dataset Information

Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair.

Purpose

Methods

Results

Conclusions

Publications

Modifying hernia mesh design to improve device mechanical performance and promote tension-free repair.

Similar Datasets

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