Dataset Information

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

ABSTRACT:

Introduction

Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months.

Methods

A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm², scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months.

Results

Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery.

Conclusion

After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations.

Trial registration

Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

SUBMITTER: Van Rooijen MMJ

PROVIDER: S-EPMC8881263 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

Van Rooijen M M J MMJ Tollens T T Jørgensen L N LN de Vries Reilingh T S TS Piessen G G Köckerling F F Miserez M M Windsor A C J ACJ Berrevoet F F Fortelny R H RH Dousset B B Woeste G G van Westreenen H L HL Gossetti F F Lange J F JF Tetteroo G W M GWM Koch A A Jeekel J J

Hernia : the journal of hernias and abdominal wall surgery 20210719 1

<h4>Introduction</h4>Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months.<h4>Methods</h4>A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm<sup>2</sup>, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes inclu ...[more]

PMID: 34282506

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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.

Project description:Pelvic organ prolapse is a common condition that affects 1 in 4 women across all age groups. It is mainly caused by vaginal birth injury and can be exacerbated by obesity and increased age. Until recently, treatment strategies often used non-degradable synthetic meshes for reconstructive surgery. However, owing to their frequent, unacceptable rate of adverse events such as mesh erosion, transvaginal meshes have been banned in many countries. Recent reports have highlighted the urgent need for biocompatible design of meshes for a safe and effective treatment in the long term. This study reports the design and evaluation of a novel, elastin based degradable mesh using an ovine model of POP as a potential surgical treatment. Elastin is a protein component of the ECM and provides elasticity to tissues throughout the body. Tropoelastin, the monomer subunit of elastin, has been used with success in electrospun constructs as it is a naturally cell interactive polymer. Biomaterials that incorporate tropoelastin support cell attachment and proliferation, and have been proven to encourage elastogenesis and angiogenesis in vitro and in vivo. The biological properties of tropoelastin were combined with the physical properties of PCL, a degradable synthetic polymer, with the aim of producing, characterizing and assessing the performance of continuous tropoelastin:PCL electrospun yarns. Using a modified spinneret electrospinning system and adjusting settings based on relative humidity, four blends of tropoelastin:PCL yarns were fabricated with concentration ratios of 75:25, 50:50, 25:75 and 0:100. Yarns were assessed for ease of manufacture, fibrous architecture, protein/polymer content, yarn stability - including initial tropoelastin release, mechanical strength, and ability to support cell growth. Based on overall favorable properties, a mesh woven from the 50:50 tropoelastin:PCL yarn was implanted into the vagina of a parous ewe with vaginal wall weakness as a model of pelvic organ prolapse. This mesh showed excellent integration with new collagen deposition by SEM and a predominant M2 macrophage response with few pro-inflammatory M1 macrophages after 30 days. The woven tropoelastin:PCL electrospun mesh shows potential as an alternative to non-degradable, synthetic pelvic organ prolapse mesh products.

Dataset Information

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

Introduction

Methods

Results

Conclusion

Trial registration

Publications

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

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