Pelvic floor disorders are frequently overlooked pathologies that nevertheless have a relevant impact on patients’ quality of life. It is estimated that 50% of women will experience PFD symptoms in their life, and this percentage is bound to increase in the upcoming years in an ever aging population. Ultimately, in these patients a surgical intervention is often required, with a lifetime risk of having a surgery estimated to be 11%, that in 30% will not however be resolutive. The high rate of treatment failure, recurrences, and complications reveals a still uncomplete understanding of pelvic floor pathophysiology and pelvic organ complex interactions. In the literature, there is still an ongoing debate regarding the optimal surgical treatment to be employed, leading to a wide variety of techniques that however rarely focus on the pelvis as a whole integrated unit. While the ultimate choice should be certainly patient tailored, it became clear how a multidisciplinary, multi-compartment approach stands as the key to revolutionize PFD management. Among numerous surgical techniques, L-POPS emerges as a promising option for its minimal invasiveness and contemporary reconstruction of the entire pelvic functional unit. L-POPs has been demonstrated to be an effective technique in patients with complex pelvic prolapse, with multiple pelvic compartments implication. However, its widespread use is still hampered by its technical complexity. The standard bulky polypropylene mesh employed in L-POPS, is in fact arduously displayed and positioned in the small pelvic space, restricting its use to expert surgeons, prolonging intervention duration and possibly affecting the technique’s efficacy itself. Furthermore, the direct contact of polypropylene with viscera may increase post-operative complication risk, especially infection and mesh erosion. We therefore propose the adoption of an innovative prosthetic mesh during L-POPS: Wing Compact Pro-Pelvic mesh. This mesh is designed to minimize the procedure complexity, thanks to mesh wings storage into two apposite pockets. Additionally, the centre of the mesh, destined to be in direct contact with viscera, is covered by a thin layer of polyurethane, providing high biocompatibility and minimizing mesh related complication risk. In a pilot study we examined the results obtained with L-POPS and Wing Compact Pro-Pelvic mesh in 25 women with complex pelvic prolapse. Preliminary results are truly encouraging, showing lack of complications and recurrence at 24 months follow-up. Significant efficacy in functional restoration was recorded, evaluated through both clinical scores and defecography, with figures equal or superior to literature’s ones. Furthermore, an important reduction in operative time was registered, with a mean intervention time 50% shorter than what reported in the literature in similar patients’ sample. Notwithstanding these propitious results, in order to thoroughly assess the true impact of this innovative mesh application, a new larger and more structured study is needed. We therefore propose a randomized, controlled study to prove the superiority of Wing Compact Pro-Pelvic mesh to the standard polypropylene mesh for L-POPS in complex pelvic organ patients, in terms of mesh manoeuvrability, safety and effectiveness. We propose a multicentric study that should hence include centres with adequate experience in laparoscopic intervention and L-POPS technique, as in the case of ASST Pavia. If future data will confirm preliminary results, L-POPS with Wing Compact Pro-Pelvic mesh will be validated as an effective, easy and safe procedure, fit to overcome the main drawbacks of L-POPS with standard mesh. This enhanced device could therefore yield a crucial improvement in L-POPS technique, extending its application to a much greater number of complex pelvic organ prolapse patients.
I disordini del pavimento pelvico sono patologie sottostimate, ma con un notevole impatto sulla qualità di vita dei pazienti affetti. Si stima che circa il 50% della popolazione femminile lamenti sintomi attribuibili ai DPP nel corso della propria vita, percentuale che è destinata a crescere nel prossimo futuro con il progressivo invecchiamento della popolazione. In queste pazienti è spesso inevitabile l’indicazione alla chirurgia ricostruttiva, con un rischio stimato del 11% di sottoporsi almeno ad un intervento chirurgico, che nel 30% dei casi non risulta risolutivo. L’alto tasso di fallimenti, complicanze e ricorrenze rivela una comprensione ancora limitata della complessa patofisiologia del pavimento pelvico. Il trattamento chirurgico ottimale è ancora molto dibattuto, è però sempre più chiara l’importanza di un approccio multidisciplinare e multi-compartimentale. La POPS e la sua variante sec. Longo offre un’opzione attraente per il trattamento del prolasso complesso degli organi pelvici offrendosi come una tecnica mini invasiva e multi-compartimentale. La diffusione del suo impiego è però limitata dalla complessità dell’intervento. La rete pelvica standard è caratterizzata da lunghe ali laterali che causano un posizionamento difficoltoso negli stretti spazi della pelvi, limitando il suo utilizzo a chirurghi esperti, prolungando i tempi operatori e possibilmente influendo sull’efficacia della tecnica stessa. Inoltre, il contatto diretto tra i visceri cavi e il polipropilene di cui è composta la rete pelvica standard può causare complicanze post operatorie, in particolare l’erosione della vagina e del retto. Proponiamo quindi di implementare una nuova rete durante la L-POPS: la Wing Compact Pro-Pelvic mesh. Questa rete è progettata per minimizzare la complessità dell’intervento, grazie alla raccolta delle alette laterali della rete in due apposite tasche, donandole una particolare compattezza. Inoltre, questa rete è caratterizzata da un sottile strato di poliuretano nella parte centrale della rete destinata ad entrare a diretto contatto con i visceri cavi, volto ad aumentarne la biocompatibilità e diminuire il rischio di complicanze. In uno studio pilota abbiamo analizzato i risultati ottenuti in 25 donne affette da prolasso complesso degli organi pelvici, trattate con L-POPS e l’implemento di Wing Compact Pro-Pelvic mesh. I risultati preliminari sono particolarmente incoraggianti, la nuova rete si è mostrata sicura, in assenza di complicanze e ricorrenze a 24 mesi di controllo. L’efficacia di riparazione è stata valutata attraverso dati clinici e strumentali, riportando valori pari o superiori a quelli presenti in letteratura per la protesi tradizionale. Inoltre, abbiamo registrato una notevole riduzione del tempo operatorio, con un tempo medio ridotto del 50% rispetto a quello registrato in letteratura per l’impiego della protesi standard in campioni paragonabili di pazienti. Nonostante gli ottimi risultati preliminari, studi più approfonditi sono senz’altro necessari per valutare appieno la potenzialità di questa nuova protesi. Per questo motivo proponiamo uno studio randomizzato e controllato per dimostrare la superiorità della Wing Compact Pro-Pelvic mesh rispetto la rete pelvica standard nel trattamento del prolasso complesso degli organi pelvici in termini di maneggevolezza, invasività ed efficacia. Proponiamo uno studio multicentrico che coinvolga centri con adeguata esperienza in interventi laparoscopici e in particolare in L-POPS, come abbiamo dimostrato essere ASST Pavia. Se questi primi risultati verranno confermati, la L-POPS con Wing Compact Pro-Pelvic mesh potrà essere validata come una tecnica semplice, sicura ed efficace, adatta a superare i principali difetti della rete pelvica standard in polipropilene e ampliarne l’indicazione a un più ampio numero di pazienti.
Laparoscopic Pelvic Organ Prolapse Suspension with a New Compact Polyurethane-Coated Mesh: Preliminary Results and Multi-Centric Study Proposal
PIAZZA, BARBARA
2021/2022
Abstract
Pelvic floor disorders are frequently overlooked pathologies that nevertheless have a relevant impact on patients’ quality of life. It is estimated that 50% of women will experience PFD symptoms in their life, and this percentage is bound to increase in the upcoming years in an ever aging population. Ultimately, in these patients a surgical intervention is often required, with a lifetime risk of having a surgery estimated to be 11%, that in 30% will not however be resolutive. The high rate of treatment failure, recurrences, and complications reveals a still uncomplete understanding of pelvic floor pathophysiology and pelvic organ complex interactions. In the literature, there is still an ongoing debate regarding the optimal surgical treatment to be employed, leading to a wide variety of techniques that however rarely focus on the pelvis as a whole integrated unit. While the ultimate choice should be certainly patient tailored, it became clear how a multidisciplinary, multi-compartment approach stands as the key to revolutionize PFD management. Among numerous surgical techniques, L-POPS emerges as a promising option for its minimal invasiveness and contemporary reconstruction of the entire pelvic functional unit. L-POPs has been demonstrated to be an effective technique in patients with complex pelvic prolapse, with multiple pelvic compartments implication. However, its widespread use is still hampered by its technical complexity. The standard bulky polypropylene mesh employed in L-POPS, is in fact arduously displayed and positioned in the small pelvic space, restricting its use to expert surgeons, prolonging intervention duration and possibly affecting the technique’s efficacy itself. Furthermore, the direct contact of polypropylene with viscera may increase post-operative complication risk, especially infection and mesh erosion. We therefore propose the adoption of an innovative prosthetic mesh during L-POPS: Wing Compact Pro-Pelvic mesh. This mesh is designed to minimize the procedure complexity, thanks to mesh wings storage into two apposite pockets. Additionally, the centre of the mesh, destined to be in direct contact with viscera, is covered by a thin layer of polyurethane, providing high biocompatibility and minimizing mesh related complication risk. In a pilot study we examined the results obtained with L-POPS and Wing Compact Pro-Pelvic mesh in 25 women with complex pelvic prolapse. Preliminary results are truly encouraging, showing lack of complications and recurrence at 24 months follow-up. Significant efficacy in functional restoration was recorded, evaluated through both clinical scores and defecography, with figures equal or superior to literature’s ones. Furthermore, an important reduction in operative time was registered, with a mean intervention time 50% shorter than what reported in the literature in similar patients’ sample. Notwithstanding these propitious results, in order to thoroughly assess the true impact of this innovative mesh application, a new larger and more structured study is needed. We therefore propose a randomized, controlled study to prove the superiority of Wing Compact Pro-Pelvic mesh to the standard polypropylene mesh for L-POPS in complex pelvic organ patients, in terms of mesh manoeuvrability, safety and effectiveness. We propose a multicentric study that should hence include centres with adequate experience in laparoscopic intervention and L-POPS technique, as in the case of ASST Pavia. If future data will confirm preliminary results, L-POPS with Wing Compact Pro-Pelvic mesh will be validated as an effective, easy and safe procedure, fit to overcome the main drawbacks of L-POPS with standard mesh. This enhanced device could therefore yield a crucial improvement in L-POPS technique, extending its application to a much greater number of complex pelvic organ prolapse patients.È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/13829