Ouldamer Lobna, Bonastre Julia, Brunet-Houdard Solène, Body Gilles, Giraudeau Bruno, Caille Agnès
Department of Gynecology, CHRU de Tours, Tours, France INSERM unit 1069, Tours, France.
Gustave Roussy, Service de Biostatistique et d'Epidemiologie, Villejuif, France CESP, Centre for Research in Epidemiology and Population Health, Villejuif, France.
BMJ Open. 2016 Apr 4;6(4):e009903. doi: 10.1136/bmjopen-2015-009903.
Postoperative 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.
This 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 χ(2) test (or Fisher's exact test).
Written 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.
NCT02263651.
乳房切除术后伤口血清肿很常见。这种并发症对患者的预后和医疗成本有重大影响。预防血清肿的最佳缝合方法尚不清楚，但一些证据表明，对死腔进行褥式缝合可能会降低血清肿的发生率。本试验的目的是比较在接受乳房切除术的患者中，使用褥式缝合与传统引流缝合预防血清肿形成的效果。
这是一项多中心、优效性、随机对照试验，纳入接受或未接受腋窝清扫的乳房切除术女性患者。排除标准包括双侧乳房切除术或即刻重建的指征，以及任何可能损害患者术后数据收集合作能力或不允许获得知情同意的身体或精神状况。320名参与者将按1:1的比例随机分组，分别接受褥式缝合或传统伤口引流缝合。主要结局是乳房切除术后21天内需要抽吸或手术干预的血清肿。次要结局包括无论是否需要干预的血清肿、手术部位感染、疼痛评分、美容效果、患者生活质量、成本和成本效益。主要分析将采用χ(2)检验（或Fisher精确检验）进行意向性分析。
将获得所有参与者的书面知情同意。本研究已获得图尔研究伦理委员会（CPP TOURS-Region Centre-Ouest 1, 2014-R20, 2014年12月16日）的批准。研究结果将发表在同行评审期刊上，并在相关的国内和国际乳腺癌会议上展示。
NCT02263651。
