Nikkels C, Vervoort Anke J M W, Mol Ben Willem, Hehenkamp Wouter J K, Huirne Judith A F, Brölmann Hans A M
Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, The Netherlands.
Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, The Netherlands.
Eur J Obstet Gynecol Reprod Biol. 2017 Aug;215:247-253. doi: 10.1016/j.ejogrb.2017.06.027. Epub 2017 Jun 23.
The research objective of the current systematic literature review is to classify the laparoscopic niche repair according to the IDEAL framework of 'innovation stages' and to recommend the required research setting to facilitate safe and properly timed implementation of the technique. In doing so, we are also able to evaluate the practical applicability of the IDEAL framework. A systematic search of the available literature on laparoscopic niche repair was performed in PubMed, Embase, and the Wiley/Cochrane library. Articles were classified according to the IDEAL framework and recommendations were given on additional required research before the technique can be safely implemented. Practical applicability of the IDEAL framework was also evaluated. Introduction of laparoscopic niche repair matches Idea (1) and Development (2a), according to the stages of IDEAL framework, although most studies are retrospective and complications have not been registered structurally in a considerable number of the articles. As feasibility and safety have been more or less established and surgery has been further developed we enter stage 2b (Exploration) and need prospective trials preferably comparing the effectiveness of laparoscopic niche repair to expectant management, the current standard care. Available studies were classified with the use of the IDEAL framework, achieving an overall IDEAL stage to be 2a Development. As clinical outcomes, though poorly registered, have been substantially improved, laparoscopic niche repair needs to be carried forward by more advanced study designs.
当前系统文献综述的研究目的是根据“创新阶段”的IDEAL框架对腹腔镜切口疝修补术进行分类，并推荐所需的研究设置，以促进该技术的安全及适时实施。在此过程中，我们还能够评估IDEAL框架的实际适用性。在PubMed、Embase和Wiley/Cochrane图书馆中对有关腹腔镜切口疝修补术的现有文献进行了系统检索。根据IDEAL框架对文章进行分类，并就在安全实施该技术之前所需的额外研究给出建议。还评估了IDEAL框架的实际适用性。根据IDEAL框架的阶段，腹腔镜切口疝修补术的引入符合构想（1）和发展（2a）阶段，尽管大多数研究是回顾性的，并且相当数量的文章中未对并发症进行结构性记录。由于可行性和安全性已或多或少得到确立，且手术已进一步发展，我们进入2b阶段（探索），需要进行前瞻性试验，最好是比较腹腔镜切口疝修补术与目前标准治疗即期待治疗的有效性。利用IDEAL框架对现有研究进行分类，得出总体IDEAL阶段为2a发展阶段。由于临床结果记录不佳但已大幅改善，腹腔镜切口疝修补术需要通过更先进的研究设计来推进。
