Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.
Biosynthetic mesh
Hernia recurrence
Hernia surgery
Incisional hernia
Journal
Hernia : the journal of hernias and abdominal wall surgery
ISSN: 1248-9204
Titre abrégé: Hernia
Pays: France
ID NLM: 9715168
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
20
04
2021
accepted:
27
06
2021
pubmed:
21
7
2021
medline:
3
5
2022
entrez:
20
7
2021
Statut:
ppublish
Résumé
Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. 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 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. 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. Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.
Identifiants
pubmed: 34282506
doi: 10.1007/s10029-021-02453-1
pii: 10.1007/s10029-021-02453-1
pmc: PMC8881263
doi:
Banques de données
ClinicalTrials.gov
['NCT02720042']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
131-138Informations de copyright
© 2021. The Author(s).
Références
Luijendijk RW, Hop WC, van den Tol MP et al (2000) A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 343:392–398. https://doi.org/10.1056/NEJM200008103430603
doi: 10.1056/NEJM200008103430603
pubmed: 10933738
van Ramshorst GH, Eker HH, Hop WC et al (2012) Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study. Am J Surg 204:144–150. https://doi.org/10.1016/j.amjsurg.2012.01.012
doi: 10.1016/j.amjsurg.2012.01.012
pubmed: 22579232
Burger JW, Luijendijk RW, Hop WC et al (2004) Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 240:578–583 (discussion 583-575)
doi: 10.1097/01.sla.0000141193.08524.e7
Mathes T, Walgenbach M, Siegel R (2016) Suture versus mesh repair in primary and incisional ventral hernias: a systematic review and meta-analysis. World J Surg 40:826–835. https://doi.org/10.1007/s00268-015-3311-2
doi: 10.1007/s00268-015-3311-2
pubmed: 26563217
Cobb WS, Kercher KW, Heniford BT (2005) Laparoscopic repair of incisional hernias. Surg Clin North Am 85:91–103, ix. https://doi.org/10.1016/j.suc.2004.09.006
doi: 10.1016/j.suc.2004.09.006
pubmed: 15619531
White TJ, Santos MC, Thompson JS (1998) Factors affecting wound complications in repair of ventral hernias. Am Surg 64:276–280
pubmed: 9520825
Falagas ME, Kasiakou SK (2005) Mesh-related infections after hernia repair surgery. Clin Microbiol Infect 11:3–8. https://doi.org/10.1111/j.1469-0691.2004.01014.x
doi: 10.1111/j.1469-0691.2004.01014.x
pubmed: 15649297
FitzGerald JF, Kumar AS (2014) Biologic versus synthetic mesh reinforcement: what are the pros and cons? Clin Colon Rectal Surg 27:140–148. https://doi.org/10.1055/s-0034-1394155
doi: 10.1055/s-0034-1394155
pubmed: 26106284
pmcid: 4477030
Petro CC, Rosen MJ (2018) A current review of long-acting resorbable meshes in abdominal wall reconstruction. Plast Reconstr Surg 142:84S-91S. https://doi.org/10.1097/PRS.0000000000004859
doi: 10.1097/PRS.0000000000004859
pubmed: 30138274
Deeken CR, Matthews BD (2013) Characterization of the mechanical strength, resorption properties, and histologic characteristics of a fully absorbable material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a porcine model of hernia repair. ISRN Surg 2013:238067. https://doi.org/10.1155/2013/238067
doi: 10.1155/2013/238067
pubmed: 23781348
pmcid: 3679684
Martin DP, Badhwar A, Shah DV et al (2013) Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res 184:766–773. https://doi.org/10.1016/j.jss.2013.03.044
doi: 10.1016/j.jss.2013.03.044
pubmed: 23582230
Gobin AS, Butler CE, Mathur AB (2006) Repair and regeneration of the abdominal wall musculofascial defect using silk fibroin-chitosan blend. Tissue Eng 12:3383–3394. https://doi.org/10.1089/ten.2006.12.3383
doi: 10.1089/ten.2006.12.3383
pubmed: 17518675
Bonewald L (2019) Use it or lose it to age: a review of bone and muscle communication. Bone 120:212–218. https://doi.org/10.1016/j.bone.2018.11.002
doi: 10.1016/j.bone.2018.11.002
pubmed: 30408611
Ventral Hernia Working Group, Breuing K, Butler CE et al (2010) Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery 148:544–558. https://doi.org/10.1016/j.surg.2010.01.008
doi: 10.1016/j.surg.2010.01.008
van Rooijen M, Jairam A, Tollens T et al (2020) Outcomes of a new slowly resorbable biosynthetic mesh (Phasix) in potentially contaminated incisional hernias: a prospective, multi-center, single-arm trial. Int J Surg 83:31–36. https://doi.org/10.1016/j.ijsu.2020.08.053
doi: 10.1016/j.ijsu.2020.08.053
pubmed: 32931978
Miserez M, Jairam AP, Boersema GSA et al (2019) Resorbable synthetic meshes for abdominal wall defects in preclinical setting: a literature review. J Surg Res 237:67–75. https://doi.org/10.1016/j.jss.2018.11.054
doi: 10.1016/j.jss.2018.11.054
pubmed: 30710881
van Rooijen MMJ, Jairam AP, Tollens T et al (2018) A post-market, prospective, multi-center, single-arm clinical investigation of Phasix mesh for VHWG grade 3 midline incisional hernia repair: a research protocol. BMC Surg 18:104. https://doi.org/10.1186/s12893-018-0439-7
doi: 10.1186/s12893-018-0439-7
pubmed: 30458747
pmcid: 6247668
Heniford BT, Walters AL, Lincourt AE et al (2008) Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg 206:638–644. https://doi.org/10.1016/j.jamcollsurg.2007.11.025
doi: 10.1016/j.jamcollsurg.2007.11.025
pubmed: 18387468
EuroQol Group (1990) EuroQol–a new facility for the measurement of health-related quality of life. Health Policy 16:199–208
doi: 10.1016/0168-8510(90)90421-9
Centers for Disease Control and Prevention (CDC) Guideline for the Prevention of Surgical Site Infection (2017)
ClinicalTrials.gov [Internet] Identifier NCT02053168 (2014) A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair, Bethesda (MD), National Library of Medicine (US)
Roth JS, Anthone GJ, Selzer DJ et al (2018) Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up. Surg Endosc 32:1929–1936. https://doi.org/10.1007/s00464-017-5886-1
doi: 10.1007/s00464-017-5886-1
pubmed: 29063307
Christopher AN, Morris MP, Patel V et al (2021) An evaluation of clinical and quality of life outcomes after ventral hernia repair with poly-4-hydroxybutyrate mesh. Hernia. https://doi.org/10.1007/s10029-021-02394-9
doi: 10.1007/s10029-021-02394-9
pubmed: 33907919
Charleux-Muller D, Hurel R, Fabacher T et al (2021) Slowly absorbable mesh in contaminated incisional hernia repair: results of a French multicenter study. Hernia. https://doi.org/10.1007/s10029-020-02366-5
doi: 10.1007/s10029-020-02366-5
pubmed: 33492554
Brahmbhatt R, Carter SA, Hicks SC et al (2014) Identifying risk factors for surgical site complications after laparoscopic ventral hernia repair: evaluation of the Ventral Hernia Working Group grading system. Surg Infect (Larchmt) 15:187–193. https://doi.org/10.1089/sur.2012.179
doi: 10.1089/sur.2012.179
Skipworth JR, Vyas S, Uppal L et al (2014) Improved outcomes in the management of high-risk incisional hernias utilizing biological mesh and soft-tissue reconstruction: a single center experience. World J Surg 38:1026–1034. https://doi.org/10.1007/s00268-013-2442-6
doi: 10.1007/s00268-013-2442-6
pubmed: 24390228
Baldan N, Munegato G, Di Leo A et al (2020) Lessons learned from 227 biological meshes used for the surgical treatment of ventral abdominal defects. Hernia 24:57–65. https://doi.org/10.1007/s10029-019-01883-2
doi: 10.1007/s10029-019-01883-2
pubmed: 30661179
Kanters AE, Krpata DM, Blatnik JA et al (2012) Modified hernia grading scale to stratify surgical site occurrence after open ventral hernia repairs. J Am Coll Surg 215:787–793. https://doi.org/10.1016/j.jamcollsurg.2012.08.012
doi: 10.1016/j.jamcollsurg.2012.08.012
pubmed: 22999328
Romain B, Renard Y, Binquet C et al (2020) Recurrence after elective incisional hernia repair is more frequent than you think: an international prospective cohort from the French Society of Surgery. Surgery 168:125–134. https://doi.org/10.1016/j.surg.2020.02.016
doi: 10.1016/j.surg.2020.02.016
pubmed: 32305229
Warren J, Desai SS, Boswell ND et al (2020) Safety and efficacy of synthetic mesh for ventral hernia repair in a contaminated field. J Am Coll Surg 230:405–413. https://doi.org/10.1016/j.jamcollsurg.2019.12.008
doi: 10.1016/j.jamcollsurg.2019.12.008
pubmed: 31954819
Jamadar DA, Jacobson JA, Girish G et al (2008) Abdominal wall hernia mesh repair: sonography of mesh and common complications. J Ultrasound Med 27:907–917. https://doi.org/10.7863/jum.2008.27.6.907
doi: 10.7863/jum.2008.27.6.907
pubmed: 18499850
Alshamali M, Sallam S, Alzaid D et al (2020) Enterocutaneous fistula occurring 10 years after an open umbilical hernia repair with placement of an onlay polypropylene mesh: a case report. Int J Surg Case Rep 67:123–126. https://doi.org/10.1016/j.ijscr.2020.02.004
doi: 10.1016/j.ijscr.2020.02.004
pubmed: 32062115
pmcid: 7016344
Saxena K, Saini R (2019) Enterocutaneous fistula secondary to mesh erosion of bowel: a late complication of polypropylene mesh use in ventral hernia repair. Int Surg J. https://doi.org/10.18203/2349-2902.isj20195146
doi: 10.18203/2349-2902.isj20195146
Patel R, Reid TH, Parker SG et al (2018) Intraluminal mesh migration causing enteroenteric and enterocutaneous fistula: a case and discussion of the “mesh problem.” BMJ Case Rep. https://doi.org/10.1136/bcr-2017-223476
doi: 10.1136/bcr-2017-223476
pubmed: 30567143
pmcid: 6301505
Messa CAt, Kozak G, Broach RB et al (2019) When the mesh goes away: an analysis of poly-4-hydroxybutyrate mesh for complex hernia repair. Plast Reconstr Surg Glob Open 7:e2576. https://doi.org/10.1097/GOX.0000000000002576
doi: 10.1097/GOX.0000000000002576
pubmed: 31942324
pmcid: 6908335
Rosen MJ, Bauer JJ, Harmaty M et al (2017) Multicenter, prospective, longitudinal study of the recurrence, surgical site infection, and quality of life after contaminated ventral hernia repair using biosynthetic absorbable mesh: the COBRA study. Ann Surg 265:205–211. https://doi.org/10.1097/SLA.0000000000001601
doi: 10.1097/SLA.0000000000001601
pubmed: 28009747
Rogmark P, Petersson U, Bringman S et al (2016) Quality of life and surgical outcome 1 year after open and laparoscopic incisional hernia repair: PROLOVE: a randomized controlled trial. Ann Surg 263:244–250. https://doi.org/10.1097/SLA.0000000000001305
doi: 10.1097/SLA.0000000000001305
pubmed: 26135682
Jensen KK, Emmertsen KJ, Laurberg S et al (2020) Long-term impact of incisional hernia on quality of life after colonic cancer resection. Hernia 24:265–272. https://doi.org/10.1007/s10029-019-01978-w
doi: 10.1007/s10029-019-01978-w
pubmed: 31127401
Pereira JA, Montcusi B, Lopez-Cano M et al (2018) Risk factors for bad outcomes in incisional hernia repair: lessons learned from the National Registry of Incisional Hernia (EVEREG). Cir Esp 96:436–442. https://doi.org/10.1016/j.ciresp.2018.03.008
doi: 10.1016/j.ciresp.2018.03.008
pubmed: 29754694
Rognoni C, Bassi UA, Cataldo M et al (2018) Budget impact analysis of a biosynthetic mesh for incisional hernia repair. Clin Ther 40(1830–1844):e1834. https://doi.org/10.1016/j.clinthera.2018.09.003
doi: 10.1016/j.clinthera.2018.09.003