Larouche Maryse, Geoffrion Roxana, Walter Jens-Erik
Montréal, QC.
Vancouver, BC.
J Obstet Gynaecol Can. 2017 Nov;39(11):1085-1097. doi: 10.1016/j.jogc.2017.05.006.
This guideline reviews the evidence related to the risks and benefits of using transvaginal mesh in pelvic organ prolapse repairs in order to update recommendations initially made in 2011.
Gynaecologists, residents, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with pelvic organ prolapse.
Adult women with symptomatic pelvic organ prolapse considering surgery and those who have previously undergone transvaginal mesh procedures for the treatment of pelvic organ prolapse.
The discussion relates to transvaginal mesh procedures compared with other surgical options for pelvic organ prolapse (mainly about vaginal native tissue repairs and minimally about other alternatives such as biological and absorbable vaginal mesh and abdominally placed surgical mesh).
The outcomes of interest are objective and subjective success rates and intraoperative and postoperative complications, such as adjacent organ injury (urinary, gastrointestinal), infection, hematoma/bleeding, vaginal mesh exposure, persistent pain, dyspareunia, de novo stress urinary incontinence, and reoperation.
PubMed, Medline, the Cochrane Database, and EMBASE were searched using the key words pelvic organ prolapse/surgery*, prolapse/surgery*, surgical mesh, surgical mesh*/adverse effects, transvaginal mesh, and pelvic organ prolapse.
were restricted to English or French language and human research. Articles obtained through this search strategy were included until the end of June 2016. Pertinent new studies were added up to September 2016. Grey literature was not searched. Clinical practice guidelines and guidelines of specialty societies were reviewed. Systematic reviews were included when available. Randomized controlled trials and observational studies were included when evidence for the outcome of interest or in the target population was not available from systematic reviews. New studies not yet included in systematic reviews were also included. Only publications with study groups larger than 20 individuals were selected because this criterion was used in the largest meta-analysis referenced in this guideline. A total of 1470 studies were obtained; after selecting only applicable studies and excluding duplicates, 68 manuscripts were reviewed and included.
The content and recommendations were drafted and agreed upon by the principal authors and members of the Urogynaecology Committee. The Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation methodology framework. The Summary of Findings is available upon request.
BENEFITS, HARMS, AND/OR COSTS: It is expected that this guideline will benefit women with pelvic organ prolapse by ensuring that health care providers are aware of outcomes related to transvaginal mesh procedures and steps in the management of related complications. This should guide patient-informed consent before such procedures are undertaken. The benefits clearly outweigh the potential harms or costs of implementation of this guideline, although no direct harms or costs are identified.
Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations.
RECOMMENDATIONS.
本指南回顾了与盆腔器官脱垂修复中使用经阴道网片的风险和益处相关的证据,以便更新2011年最初提出的建议。
评估、咨询和护理盆腔器官脱垂女性的妇科医生、住院医师、泌尿科医生、泌尿妇科医生及其他医疗服务提供者。
考虑手术治疗的有症状盆腔器官脱垂成年女性,以及先前已接受经阴道网片手术治疗盆腔器官脱垂的女性。
讨论内容为经阴道网片手术与盆腔器官脱垂的其他手术选择(主要是阴道自体组织修复,极少涉及其他替代方案,如生物和可吸收阴道网片以及经腹放置的手术网片)的比较。
关注的结果为客观和主观成功率以及术中及术后并发症,如邻近器官损伤(泌尿、胃肠道)、感染、血肿/出血、阴道网片暴露、持续性疼痛、性交困难、新发压力性尿失禁及再次手术。
使用关键词“盆腔器官脱垂/手术*”“脱垂/手术*”“手术网片”“手术网片*/不良反应”“经阴道网片”和“盆腔器官脱垂”检索了PubMed、Medline、Cochrane数据库和EMBASE。
仅限于英文或法文文献及人体研究。通过该检索策略获得的文章纳入至2016年6月底。相关新研究补充至2016年9月。未检索灰色文献。对临床实践指南和专业学会指南进行了回顾。如有可用的系统评价则纳入。当系统评价未提供目标人群中关注结果的证据时,纳入随机对照试验和观察性研究。尚未纳入系统评价的新研究也纳入。仅选择研究组大于20人的出版物,因为本指南引用的最大荟萃分析采用了该标准。共获得1470项研究;仅选择适用研究并排除重复项后,对68篇手稿进行了审查并纳入。
内容和建议由主要作者及泌尿妇科委员会成员起草并达成一致。加拿大妇产科医师协会理事会批准了最终出版草案。使用推荐分级评估、制定和评价方法框架中描述的标准对证据质量进行评级。如有需要可提供结果总结。
益处、危害和/或成本:预计本指南将使盆腔器官脱垂女性受益,确保医疗服务提供者了解经阴道网片手术相关结果及相关并发症的处理步骤。这应指导此类手术前的患者知情同意。尽管未确定直接危害或成本,但本指南实施的益处明显超过潜在危害或成本。
出版5年后将对证据进行审查,以决定是否应更新全部或部分指南。然而,如果在5年周期之前发表了重要新证据,可能会加快审查过程,以便更快更新一些建议。
建议。