Sir Alan Parks Physiology Unit, St. Mark's Hospital, Harrow, UK.
Imperial College, London, UK.
Tech Coloproctol. 2017 Apr;21(4):277-286. doi: 10.1007/s10151-017-1613-0. Epub 2017 Apr 20.
Sacral neuromodulation has been reported as a treatment for severe idiopathic constipation. This study aimed to evaluate the long-term effects of sacral neuromodulation by following patients who participated in a prospective, open-label, multicentre study up to 5 years.
Patients were followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months. Symptoms and quality of life were assessed using bowel diary, the Cleveland Clinic constipation score and the Short Form-36 quality-of-life scale.
Sixty-two patients (7 male, median age 40 years) underwent test stimulation, and 45 proceeded to permanent implantation. Twenty-seven patients exited the study (7 withdrawn consent, 7 loss of efficacy, 6 site-specific reasons, 4 withdrew other reasons, 2 lost to follow-up, 1 prior to follow-up). Eighteen patients (29%) attended 60-month follow-up. In 10 patients who submitted bowel diary, their improvement of symptoms was sustained: the number of defecations per week (4.1 ± 3.7 vs 8.1 ± 3.4, mean ± standard deviation, p < 0.001, baseline vs 60 months) and sensation of incomplete emptying (0.8 ± 0.3 vs 0.2 ± 0.1, p = 0.002). In 14 patients (23%) with Cleveland Clinic constipation score, improvement was sustained at 60 months [17.9 ± 4.4 (baseline) to 10.4 ± 4.1, p < 0.001]. Some 103 device-related adverse events were reported in 27 (61%).
Benefit from sacral neuromodulation in the long-term was observed in a small minority of patients with intractable constipation. The results should be interpreted with caution given the high dropout and complication rate during the follow-up period.
骶神经调节已被报道可用于治疗严重特发性便秘。本研究旨在通过随访参加前瞻性、开放标签、多中心研究的患者,评估骶神经调节的长期效果,随访时间长达 5 年。
患者在 1、3、6、12、24、36、48 和 60 个月时进行随访。使用排便日记、克利夫兰便秘评分和健康调查简表 36 项版评估症状和生活质量。
62 例患者(7 例男性,中位年龄 40 岁)接受了测试刺激,45 例患者进行了永久性植入。27 例患者退出研究(7 例撤回同意,7 例疗效丧失,6 例局部原因,4 例其他原因,2 例失访,1 例在随访前)。18 例患者(29%)参加了 60 个月的随访。在提交排便日记的 10 例患者中,其症状改善得以维持:每周排便次数(4.1±3.7 比 8.1±3.4,平均值±标准差,p<0.001,基线与 60 个月)和不完全排空感(0.8±0.3 比 0.2±0.1,p=0.002)。在克利夫兰便秘评分的 14 例患者(23%)中,60 个月时仍有改善[17.9±4.4(基线)至 10.4±4.1,p<0.001]。27 例(61%)患者报告了 103 例与装置相关的不良事件。
在长期随访中,少数难治性便秘患者观察到骶神经调节的益处。考虑到随访期间较高的失访率和并发症发生率,应谨慎解释这些结果。