Mesh, graft, or standard repair for prolapse surgery?

www.thelancet.com Published online December 20, 2016 http://dx.doi.org/10.1016/S0140-6736(16)32595-8 1 As reconstructive pelvic surgeons sought to reduce anatomical and symptomatic recurrence of transvaginal prolapse, the concept of incorporating an augmenting material was adopted. With this idea, similar to mesh-based hernia repair, health-care professionals aim to decrease anatomical recurrence of prolapse and thereby decrease the need for reoperation. In the PROSPECT study in The Lancet, Chiaris Glazener and colleagues have made progress in answering a clinically relevant question: using two parallel-group randomised controlled trials, the investigators assessed augmentation of transvaginal prolapse surgery with synthetic absorbable or non-absorbable mesh (type 1 monofi lament macroporous polypropylene) or biological grafts (porcine acellular collagen matrix, porcine small intestinal submucosa, or bovine dermal). The pragmatic design involved 65 surgeons across 35 UK sites, allowing considerable generalisability with a low risk of bias. The eff ective randomisation strategy included patients undergoing either primary or secondary repairs, further expanding the relevance of these results. Although current evidence, including that of this study, suggests that only a few women with anatomical recurrence or persistent symptoms undergo reoperation, the timeline for anatomical recurrence needs more study. If prolapse recurrence occurs shortly after a reconstructive surgery, it is probably related to the limitation of the previous surgical approach; however, recurrence of the prolapse years after the initial surgery is probably related to intervening factors such as physiological ageing or other health conditions. Generally, the goal of surgeons is to make every reasonable eff ort to address anatomical support to reduce symptoms, while recognising that no perfect correlation exists between anatomical recurrence and symptom presence. Thus for patients and their reconstructive surgeons, an important unanswered question has been whether an augmenting material improves surgical outcomes—eg, does it reduce anatomical recurrence, patient symptoms, or reoperation? If there is an advantage, is it off set in any clinically meaningful way? In Glazener and colleagues’ study, the primary outcomes of participant-reported prolapse symptoms (via questionnaire) and condition-specifi c quality-of-life scores at 1 year did not diff er between the standard repair group and either the group with standard repair augmented with synthetic mesh, or the group with standard repair augmented with a biological graft. Similarly at 2 years after surgery, neither synthetic nor biological augmenting materials improved surgical outcomes. The augmenting materials used in this study do not provide any advantage compared to native-tissue transvaginal reconstructive surgery. The pragmatic nature of this study might cause surgical trialists to question whether any specifi c material has been adequately tested as a comparator to native tissue repair techniques. Yet in this trial, each surgeon was able to select the augmenting material with which they were most comfortable, a pragmatic advantage that allowed each surgeon to do their best, rather than conforming to a protocol that called for a less familiar material or approach. Although the investigators noted no improvement in patient-reported prolapse symptoms at 2 years, to have all participants undergo clinical examination again at 2 years, instead of only once at 1 year, would have been advantageous to better understand the correlation between anatomical support and reported symptoms. Women who receive augmenting materials, especially synthetic mesh, are more likely to have material-related adverse events. Although the approximate 12% rate quoted in the scientifi c literature is not unexpected, in transvaginal repairs, these adverse events are not off set by any outcome benefi t. It is possible that augmenting materials have a benefi t that is detectable only with longer-term follow-up, and this might also be true for the risk of adverse events related to these materials. The fi ndings from Glazener and colleagues’ study support the limitations of prolapse repair surgery, with persistent symptoms or anatomical support loss in too many patients. In their study, the investigators noted that more than 80% of the participants had at least one residual, postoperative prolapse symptom. Researchers in this fi eld have the opportunity to improve surgical outcomes, as well as to better understand the origination and alternative means of addressing prolapse symptoms. Although the eff ort to incorporate augmenting materials did not provide any advantages, aff ected women still rely on their surgeons to practice high-quality, evidence-based surgery. In Mesh, graft, or standard repair for prolapse surgery?