Pediatric Surgery, Department of Surgery, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, University Hospital Erlangen, Loschgestraße 15, Erlangen, 91054, Germany.
Department of Medical Statistics, Biomathematics, and Information Processing, Medical Faculty, Mannheim of Heidelberg University, Theodor-Kutzer-Ufer 1-3, Haus 3, Ebene 4, Mannheim, 68167, Germany.
Trials. 2024 Mar 22;25(1):210. doi: 10.1186/s13063-024-08052-6.
A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to investigate effects of SNM in pediatric constipation in a prospective parallel-group trial.
A monocentric, randomized, unblinded, parallel-group trial is conducted. SNM is conducted in the invasive variant and in an innovative, external approach with adhesive electrodes (enteral neuromodulation, ENM). We include patients with constipation according to the ROME IV criteria and refractory to conventional options. Patients with functional constipation and Hirschsprung's disease are able to participate. Participants are allocated in a 1:1 ratio to either SNM or ENM group. Clinical data and quality of life is evaluated in regular check-ups. Neuromodulation is applied continuously for 3 months (end point of the study) with follow-up-points at 6 and 12 months. Findings are analyzed statistically considering a 5% significance level (p ≤ 0.05). Outcome variables are defined as change in (1) episodes of abdominal pain, (2) episodes of FI, (3) defecation frequency, (4) stool consistency. Improvement of proprioception, influence on urinary incontinence, quality of life and safety of treatment are assessed as secondary outcome variables. We expect a relevant improvement in both study groups.
This is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM).
The study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01/14/2021).
骶神经调节（SNM）对粪便失禁（FI）和生活质量的治疗效果已在成人中得到证实。然而，SNM 在儿科病例中很少使用。本研究旨在通过前瞻性平行组试验调查 SNM 在儿科便秘中的作用。
进行单中心、随机、非盲、平行组试验。SNM 采用有创变异和创新的外部贴附电极方法（肠内神经调节，ENM）。我们纳入符合 ROME IV 标准且对常规治疗无效的便秘患者。功能性便秘和先天性巨结肠的患者也有资格参加。参与者按照 1:1 的比例随机分配到 SNM 或 ENM 组。定期检查评估临床数据和生活质量。神经调节持续应用 3 个月（研究终点），并在 6 个月和 12 个月时进行随访。考虑到 5%的显著性水平（p≤0.05）进行统计分析。定义的结局变量为（1）腹痛发作次数、（2）FI 发作次数、（3）排便频率、（4）粪便稠度的变化。评估本体感觉改善、对尿失禁的影响、生活质量和治疗安全性作为次要结局变量。我们预计两个研究组都会有明显的改善。
这是第一项评估神经调节对儿童和青少年便秘作用的试验，并比较了有创和无创应用（SNM 与 ENM）的效果。
该研究在 clinicaltrials.gov 上注册，标识符为 NCT04713085（注册日期为 2021 年 1 月 14 日）。
