IntroductionPostoperative wound seroma is common after mastectomy. This complication is associated with significant impact on patient outcomes and healthcare costs. The optimal closure approach for seroma prevention remains unknown but some evidence suggests that quilting suture of the dead space could lower the incidence of seroma. The aim of this trial is to compare seroma formation using quilting suture versus conventional closure with drainage in patients undergoing mastectomy.Methods and analysisThis is a multicentre, superiority, randomised controlled trial in women undergoing mastectomy with or without axillary involvement. Exclusion criteria include indication of bilateral mastectomy or immediate reconstruction and any physical or psychiatric condition that could impair patient's ability to cooperate with postoperative data collection or that do not allow an informed consent. 320 participants will be randomised in a 1:1 ratio to receive either quilting suture or conventional wound closure with drain. The primary outcome is seroma requiring either aspiration or surgical intervention within 21 days following mastectomy. Secondary outcomes include seroma regardless of whether or not it requires an intervention, surgical site infection, pain score, cosmetic result, patient's quality of life, costs and cost-effectiveness. The primary analysis will be an intention-to treat analysis performed with a χ2 test (or Fisher's exact test).Ethics and disseminationWritten informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS—Region Centre—Ouest 1, 2014-R20, 16 December 2014). Study findings will be published in peer-reviewed journals and presented at relevant national and international breast cancer conferences.Trial registration numberNCT02263651.
Endoscopic procedures such as ureteroscopy (URS) have seen a recent increase in single-use devices. Despite all the advantages provided by disposable ureteroscopes (sURSs), their cost effectiveness remains questionable, leading most teams to use a hybrid strategy combining reusable (rURS) and disposable devices. Our study aimed to create an economic model that estimated the cut-off value of rURS procedures needed to support the profitability of a hybrid strategy (HS) for ureteroscopy. We used a budget impact analysis (BIA) model that estimated the financial impact of an HS compared to 100% sURS use. The model included hospital volume, sterilization costs and the private or public status of the institution. Although the hybrid strategy generally remains the best economic and clinical option, a predictive BIA model is recommended for the decision-making. We found that the minimal optimal proportion of rURS procedures in an HS was mainly impacted by the activity volume and overall number of sterilization procedures. Private and public institutions must consider these variables and models in order to adapt their HS and remain profitable.
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