ANDREA SARTOREDIPARTIMENTO MATERNO-NEONATALE

IRCCS BURLO GAROFOLOUNIVERSITA’ DI TRIESTE

DIMENSIONE DEL PROBLEMA• Lifetime risk di intervento chirurgico per

prolasso: 11.1%

• Negli USA circa 200.000 interventi di correzione chirurgica di prolasso in 1 anno, di cui 22.6% colporrafia anteriore e posteriore e 10.5% solo colporrafia posteriore

• Riportato tasso di reintervento dopo chirurgia per prolasso del 30%

Smith 2010

Shah 2008

Olsen 1997

DIMENSIONE DEL PROBLEMA

• Ricorrenza di prolasso anteriore dopo colporrafia anteriore > 40%

• Nel 2001 la FDA approva l’utilizzo delle mesh per via vaginale, mutuando l’esperienza della chirurgia dell’ernia

• (… e anche della TVT…)

Sand 2001Weber 2001

MEMENTO…• Scarsa conoscenza dei fattori di rischio di fallimento

della chirurgia (giovane età, elevato BMI, prolassi III-IV grado)

• Swift dimostra che il 98% delle donne risulta asintomatica se la parete vaginale prolassata si presenta entro il margine imenale

Whiteside 2004Diez-Itza 2007Salvatore 2009

Swift 2005

IL SUCCESSO IN CHIRURGIA E’ CONSEGUENTE A QUESTO CONCETTO:LA MAGGIOR PARTE DEGLI ARTICOLI UTILIZZA LO STADIO I O II, MA IL CRITERIO FONDAMENTALE DOVREBBE ESSERE L’ASSENZA DI SINTOMISENSO DI PESO E/O CORPO ESTRANEO VAGINALE ASSOCIATO ADISFUNZIONI URINARIE, DEFECATORIE O SESSUALI

LA CHIRURGIA DEL COMPARTIMENTO POSTERIORE

• Approccio transvaginale- Colporrafia posteriore (duplicatura fasciale

mediana) associata o meno a miorrafia degli elevatori

- Riparazione sito-specifica del difetto- Reti protesiche• Approccio transanale• Approccio addominale (LPT, LPS, robot)

ERNIAZIONE DEL DOUGLAS

COLPORRAFIA POSTERIORE CON DUPLICATURA FASCIALE MEDIANA

RIPARAZIONE SITO-SPECIFICA DEL DIFETTO DEL SETTO RETTO-VAGINALE

CHIRURGIA PROTESICA

OUTCOMES DELLA CHIRURGIA FASCIALE

• Colporrafia posteriore con duplicatura fasciale mediana: tasso di successo oggettivo 87% a 12 mesi e 79% a 24 mesi considerando prolasso residuo ≤ stadio I; tasso di successo oggettivo 97% a 12 mesi e 89% a 24 mesi e 87% sulla defecazione ostruita (Maher 2004)

• Colporrafia posteriore vs riparazione sito-specifica: 4% vs 11% a 12 mesi con stadio > II grado (Abramov 2005)

• Tasso globale di risoluzione anatomica con almeno 12 mesi di follow up 80-96% per colporrafia posteriore (Mellgren 1995, Kahn 1997)

• Tasso globale di risoluzione anatomica con almeno 12 mesi di follow up 82-92% per riparazione sito-specifica (Cundiff 1998, Kenton 1999, Singh 2003)

OUTCOMES DELLA CHIRURGIA PROTESICA

• MESH BIOLOGICHE: tasso di fallimento anatomico del 20% (prolasso ≥ II grado) a 12 mesi con mesh derma porcino (Altman 2006) e del 12% con sottomucosa intestinale porcina (Sung 2012)

• MESH SINTETICHE: tasso di successo 84-92% (Lim 2005, de Tayrac 2006, Milani 2005)

• KITS: tasso di successo 82-89% (Elmer 2009, Simon 2011)

NB: non viene analizzato il compartimento posteriore separatamente

NB: outcomes specifici per il compartimento posteriore sono stati analizzati e la recidiva posteriore si è manifestata nel 21.9% delle donne sottoposte a chirurgia protesica vs 18.2% delle donne sottoposte a chirurgia fasciale

TROCAR-GUIDED MESH COMPARED WITH CONVENTIONAL VAGINAL REPAIR IN RECURRENT PROLAPSE: A RANDOMIZED CONTROLLED TRIALWithagen MI, Milani AL, den Boon J, Vervest HA, Vierhout ME.Obstet Gynecol. 2011 Feb;117(2 Pt 1):242-50

OBJECTIVE: To compare efficacy and safety of trocar-guided tension-free vaginal mesh insertion with conventional vaginal prolapse repair in patients with recurrent pelvic organ prolapse.

METHODS: Patients with recurrent pelvic organ prolapse stage II or higher were randomly assigned to either conventional vaginal prolapse surgery or polypropylene mesh insertion. Primary outcome was anatomic failure (pelvic organ prolapse stage II or higher) in the treated vaginal compartments. Secondary outcomes were subjective improvement, effects on bother, quality of life, and adverse events. (…)

RESULTS: Ninety-seven women underwent conventional repair and 93 mesh repair. The follow-up rate after 12 months was 186 of 190 patients (98%). Twelve months postsurgery, anatomic failure in the treated compartment was observed in 38 of 84 patients (45.2%) in the conventional group and in eight of 83 patients (9.6%) in the mesh group (P<.001; odds ratio, 7.7; 95% confidence interval, 3.3-18). Patients in either group reported less bulge and overactive bladder symptoms. Subjective improvement was reported by 64 of 80 patients (80%) in the conventional group compared with 63 of 78 patients (81%) in the mesh group. Mesh exposure was detected in 14 of 83 patients (16.9%).

CONCLUSION: At 12 months, the number of anatomic failures observed after tension-free vaginal mesh insertion was less than after conventional vaginal prolapse repair. Symptom decrease and improvement of quality of life were equal in both groups.

NB: recidiva posteriore 4.2% nelle mesh vs 24.5% nella chirurgia fasciale

Int Urogynecol J. 2015 Aug;26(8):1161-70VAGINAL MESH FOR PROLAPSE: A LONG-TERM PROSPECTIVE STUDY OF 218 MESH KITS FROM A SINGLE CENTREKarmakar D, Hayward L, Smalldridge J, Lin S.

INTRODUCTION AND HYPOTHESIS: The aim was to assess the long-term surgical outcomes and complications in patients undergoing mesh-augmented vaginal repair of pelvic organ prolapse.

METHODS: This is a report of a prospective long-term follow-up experience from the Urogynaecological Service, Counties Manukau District Health Board, Auckland, New Zealand. The subjects were 158 symptomatic women undergoing mesh-augmented prolapse repair (218 kits, Feb 2005 to July 2013) using the Apogee and/or Perigee kits.

RESULTS: The median follow-up times were 138 and 105 weeks for the Apogee and Perigee kits, respectively; 56.6% and 48.8% of these kits, respectively, were inserted for recurrent prolapse. Cure rates for prolapse using mesh kits in patients with a history of native tissue POP repair in the same compartment were 90.91% for the anterior compartment (60 of 66) and 95.74% for the posterior compartment (45 of 47). The cumulative mesh extrusion/exposure rate was 15.8% of patients (11.5% of mesh kits) and was significantly higher with the Apogee kit than with the Perigee kit (P = 0.03). There was a significantly higher rate of extrusion/exposure with the Perigee kit in women with previous anterior compartment native tissue repair than with the Apogee kit in women with previous posterior compartment native tissue repair (21.2% versus 6.4%; P = 0.03). Only 8% of extrusions/exposures needed revision of the mesh.. Overall success rates were 81.4% (110/135) for the Perigee kit and 74.7% (62/83) for the Apogee kit.

CONCLUSIONS: This is one of the longest prospective mesh follow-up studies to date from a single centre and highlights the need for continuing surveillance despite high overall success rates.

In particular, the literature review revealed that:

- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.

-Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.

-There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.

- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

U.S. Food and Drug AdministrationProtecting and Promoting Your Health

UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication

Date Issued: July 13, 2011

TAKE HOME MESSAGES• Duplicazione fasciale posteriore > riparazione

sito-specifica in termini di outcome oggettivi (grado B)

• Miorrafia elevatori aumenta la dispareunia (grado C)

• Approccio transvaginale superiore a transanale (grado A)

• Nessuna evidenza di qualsiasi beneficio da uso di mesh o di patches biologici (grado B)

• La sintomatologia migliora nella maggior parte delle pazienti (grado B)