Surgical Research Unit, Aarhus University Hospital, Aarhus, Denmark.
Dis Colon Rectum. 2010 Jul;53(7):995-9. doi: 10.1007/DCR.0b013e3181d64207.
Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events.
A retrospective review was performed on patients who underwent sacral nerve stimulation for constipation between August 2002 and September 2008. Collected data included patients' demographic data, type and management of suboptimal outcomes and complications, and stimulation parameters at the time of reportable events.
Thirty-eight patients (32 women; mean age, 45.6 y; SD, 11.8; range, 21-66) received a permanent stimulator after a successful test period. The mean treatment duration was 25.7 months (SD, 20.4; range, 0-70). Twenty-two patients (58%) experienced at least one reportable event attributable to the treatment. The total of 58 reportable events were noted, including lack or loss of efficacy, pain, and undesired change of sensation. Reprogramming successfully managed 28 reportable events (48%), 19 events (33%) required surgical interventions, and 3 adverse events led to discontinuation of the treatment.
Nearly 60% of patients who received sacral nerve stimulation for constipation experienced at least one reportable event. Although the events were often resolved by reprogramming, more than one-third required surgical intervention or discontinuation of therapy. Patients undergoing sacral nerve stimulation for constipation need to be informed of these possibilities. A systematic assessment is needed to identify the cause and optimize the management of reportable events.
骶神经刺激是一种治疗严重便秘的新兴方法。目前尚未有关于效果不佳和并发症的大量报告。我们报告了我们 6 年多的经验,重点关注不良事件和应报告事件的管理。
对 2002 年 8 月至 2008 年 9 月期间因便秘接受骶神经刺激的患者进行回顾性分析。收集的数据包括患者的人口统计学数据、不良事件和并发症的类型和处理、以及报告事件时的刺激参数。
38 名患者(32 名女性;平均年龄 45.6 岁;标准差 11.8;范围 21-66)在成功的测试期后接受了永久性刺激器。平均治疗时间为 25.7 个月(标准差 20.4;范围 0-70)。22 名患者(58%)至少经历了一次与治疗相关的应报告事件。共记录了 58 次应报告事件,包括疗效缺乏或丧失、疼痛和感觉异常。重新编程成功处理了 28 次应报告事件(48%),19 次事件(33%)需要手术干预,3 次不良事件导致治疗停止。
近 60%接受骶神经刺激治疗便秘的患者经历了至少一次应报告事件。尽管这些事件通常通过重新编程得到解决,但仍有三分之一以上需要手术干预或停止治疗。接受骶神经刺激治疗便秘的患者需要了解这些可能性。需要进行系统评估以确定原因并优化应报告事件的管理。