Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, The Netherlands.
Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.
Colorectal Dis. 2024 Mar;26(3):417-427. doi: 10.1111/codi.16876. Epub 2024 Jan 21.
Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC).
OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios.
Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs.
Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.
骶神经调节（SNM）是治疗功能性便秘的一种微创治疗选择。由于研究人群和设计存在异质性，其有效性的证据相互矛盾。本研究旨在评估 SNM 对难治性特发性慢传输型便秘（STC）儿童和成人的有效性、安全性和成本效益。
检索 OVID Medline、OVID Embase、Cochrane 图书馆、KSR 循证数据库、NHS 经济评估数据库和国际 HTA 数据库，检索时间截至 2023 年 5 月 25 日。对于有效性结局，选择随机对照试验（RCT）。对于安全性结局，选择所有研究设计。对于成本效益结局，选择基于试验和模型的经济评估进行综述。两名评审员独立进行研究选择、偏倚风险和质量评估以及数据提取。对于干预措施“骶神经调节”，有效性结局包括排便频率和便秘严重程度。安全性和成本效益结局分别为不良事件和增量成本效益比。
共回顾了 1390 条记录，其中 67 项研究被选入全文筛选。对于有效性，纳入了一项交叉对照试验和一项平行组 RCT，结果相互矛盾。纳入了 11 项安全性研究（4 项 RCT、3 项前瞻性队列研究和 4 项回顾性队列研究）。总体感染率在 0%到 22%之间变化，而再次手术率在 0%到 29%之间变化。纳入了一项基于试验的经济评估，该评估得出结论，与 6 个月时间框架内的个性化保守治疗相比，SNM 不具有成本效益。由于可用研究数量较少以及研究人群、难治性特发性 STC 的定义和研究设计方面的异质性，本综述的研究结果存在局限性。
SNM 对难治性特发性 STC 儿童和成人的（成本）有效性的证据尚无定论。报告的再手术率高达 29%。
