Glazener Cathryn, Breeman Suzanne, Elders Andrew, Hemming Christine, Cooper Kevin, Freeman Robert, Smith Anthony, Hagen Suzanne, Montgomery Isobel, Kilonzo Mary, Boyers Dwayne, McDonald Alison, McPherson Gladys, MacLennan Graeme, Norrie John
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK.
Health Technol Assess. 2016 Dec;20(95):1-452. doi: 10.3310/hta20950.
The use of mesh in prolapse surgery is controversial, leading to a number of enquiries into its safety and efficacy.
To compare synthetic non-absorbable mesh inlay, biological graft and mesh kit with a standard repair in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness.
Two randomised controlled trials within a comprehensive cohort (CC) study. Allocation was by a remote web-based randomisation system in a 1 :1 : 1 ratio (Primary trial) or 1 : 1 : 2 ratio (Secondary trial), and was minimised on age, type of prolapse repair planned, need for a concomitant continence procedure, need for a concomitant upper vaginal prolapse procedure and surgeon. Participants and outcome assessors were blinded to randomisation; participants were unblinded if they requested the information. Surgeons were not blinded to allocated procedure.
Thirty-five UK hospitals.
: 2474 women in the analysis (including 1348 randomised) having primary anterior or posterior prolapse surgery. : 398 in the analysis (including 154 randomised) having repeat anterior or posterior prolapse surgery. : 215 women having either uterine or vault prolapse repair.
Anterior or posterior repair alone, or with mesh inlay, biological graft or mesh kit.
Prolapse symptoms [Pelvic Organ Prolapse Symptom Score (POP-SS)]; prolapse-specific QoL; cost-effectiveness [incremental cost per quality-adjusted life-year (QALY)].
: adjusting for baseline and minimisation covariates, mean POP-SS was similar for each comparison {standard 5.4 [standard deviation (SD) 5.5] vs. mesh 5.5 (SD 5.1), mean difference (MD) 0.00, 95% confidence interval (CI) -0.70 to 0.71; standard 5.5 (SD 5.6) vs. graft 5.6 (SD 5.6), MD -0.15, 95% CI -0.93 to 0.63}. Serious non-mesh adverse effects rates were similar between the groups in year 1 [standard 7.2% vs. mesh 7.8%, risk ratio (RR) 1.08, 95% CI 0.68 to 1.72; standard 6.3% vs. graft 9.8%, RR 1.57, 95% CI 0.95 to 2.59]. There were no statistically significant differences between groups in any other outcome measure. The cumulative mesh complication rates over 2 years were 2 of 430 (0.5%) for standard repair (trial 1), 46 of 435 (10.6%) for mesh inlay and 2 of 368 (0.5%) for biological graft. The CC findings were comparable. Incremental costs were £363 (95% CI -£32 to £758) and £565 (95% CI £180 to £950) for mesh and graft vs. standard, respectively. Incremental QALYs were 0.071 (95% CI -0.004 to 0.145) and 0.039 (95% CI -0.041 to 0.120) for mesh and graft vs. standard, respectively. A Markov decision model extrapolating trial results over 5 years showed standard repair had the highest probability of cost-effectiveness, but results were surrounded by considerable uncertainty. : there were no statistically significant differences between the randomised groups in any outcome measure, but the sample size was too small to be conclusive. The cumulative mesh complication rates over 2 years were 7 of 52 (13.5%) for mesh inlay and 4 of 46 (8.7%) for mesh kit, with no mesh exposures for standard repair.
In women who were having primary repairs, there was evidence of no benefit from the use of mesh inlay or biological graft compared with standard repair in terms of efficacy, QoL or adverse effects (other than mesh complications) in the short term. The Secondary trials were too small to provide conclusive results.
Women in the Primary trials included some with a previous repair in another compartment. Follow-up is vital to identify any long-term potential benefits and serious adverse effects.
Long-term follow-up to at least 6 years after surgery is ongoing to identify recurrence rates, need for further prolapse surgery, adverse effects and cost-effectiveness.
Current Controlled Trials ISRCTN60695184.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 20, No. 95. See the NIHR Journals Library website for further project information.
在脱垂手术中使用补片存在争议，引发了对其安全性和有效性的诸多调查。
比较合成不可吸收补片植入、生物移植物和补片套件与标准修复术在临床疗效、不良反应、生活质量（QoL）、成本及成本效益方面的差异。
在一项综合队列（CC）研究中进行两项随机对照试验。通过基于网络的远程随机化系统按1:1:1比例（主要试验）或1:1:2比例（次要试验）进行分配，并根据年龄、计划的脱垂修复类型、是否需要同时进行控尿手术、是否需要同时进行阴道上部脱垂手术以及外科医生进行最小化处理。参与者和结果评估者对随机化不知情；如果参与者要求提供信息，则会取消其不知情状态。外科医生对分配的手术方案知情。
英国35家医院。
分析中有2474名女性（包括1348名随机分组者）接受初次前壁或后壁脱垂手术。分析中有398名女性（包括154名随机分组者）接受再次前壁或后壁脱垂手术。215名女性接受子宫或穹窿脱垂修复。
单独进行前壁或后壁修复，或联合补片植入、生物移植物或补片套件。
脱垂症状[盆腔器官脱垂症状评分（POP-SS）]；脱垂特异性生活质量；成本效益[每质量调整生命年（QALY）的增量成本]。
调整基线和最小化协变量后，各比较组的平均POP-SS相似{标准修复组为5.4[标准差（SD）5.5]，补片组为5.5（SD 5.1），平均差值（MD）为0.00，95%置信区间（CI）为-0.70至0.71；标准修复组为5.5（SD 5.6），移植物组为5.6（SD 5.6），MD为-0.15，95%CI为-0.93至0.63}。第1年各治疗组严重非补片相关不良反应发生率相似[标准修复组为7.2%，补片组为7.8%，风险比（RR）为1.08，95%CI为0.68至1.72；标准修复组为6.3%，移植物组为9.8%，RR为1.57，95%CI为0.95至2.59]。在任何其他观察指标上，各治疗组之间均无统计学显著差异。标准修复术（试验1）2年累计补片并发症发生率为430例中的2例（0.5%），补片植入组为435例中的46例（10.6%），生物移植物组为368例中的2例（0.5%）。CC研究结果具有可比性。与标准修复术相比，补片和移植物的增量成本分别为363英镑（95%CI为-32英镑至758英镑）和565英镑（95%CI为180英镑至950英镑）。与标准修复术相比，补片和移植物的增量QALY分别为0.071（95%CI为-0.004至0.145）和0.039（95%CI为-0.041至0.120）。一项将试验结果外推至5年的马尔可夫决策模型显示，标准修复术具有最高的成本效益概率，但结果存在相当大的不确定性。在任何观察指标上，随机分组组之间均无统计学显著差异，但样本量过小，无法得出结论。2年累计补片并发症发生率为补片植入组52例中的7例（13.5%），补片套件组46例中的4例（8.7%），标准修复术无补片暴露情况。
在接受初次修复的女性中，短期内在疗效（除补片并发症外）、生活质量或不良反应方面，与标准修复术相比，使用补片植入或生物移植物并无益处。次要试验样本量过小，无法得出确凿结果。
主要试验中的女性包括一些之前在其他部位接受过修复的患者。随访对于确定任何长期潜在益处和严重不良反应至关重要。
正在进行至少术后6年的长期随访，以确定复发率、是否需要进一步进行脱垂手术、不良反应及成本效益。
当前受控试验ISRCTN60695184。
本项目由英国国家卫生研究院（NIHR）卫生技术评估项目资助，并将全文发表于《》第20卷，第95期。有关该项目的更多信息，请访问NIHR期刊图书馆网站。
