Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Treatment success at 6 months
研究概览
简要总结
Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit) constipation is of suboptimal quality. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group.
Objective: The main objective of this study is to assess the effectiveness of SNM compared to personalized conservative treatment (PCT), in patients with idiopathic slow-transit constipation who are refractory to conservative treatment. The secondary objectives are assessing the 1) costs, 2) cost-effectiveness and 3) budget-impact of SNM compared to PCT.
Hypothesis: Based on previous research we hypothesize that SNM will be more effective than PCT in terms of a significantly higher proportion of patients having treatment success at 6 months.
Study design: An open-label pragmatic randomized controlled trial (RCT) combined with a prospective cohort study.
Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic slow-transit constipation refractory to conservative treatment.
Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of two phases. In the screening phase an electrode is inserted near the third sacral nerve and connected to an external stimulator. If the screening phase is successful (average defecation frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the buttocks of the patient. If not successful, patients receive conservative treatment. The control intervention is PCT. This is the best and least invasive alternative to SNM. PCT consists of medication and/or retrograde colonic irrigation.
Main study parameters/endpoints: The primary outcome is success at 6 months, defined as an average DF of ≥3 a week according to a 3-week defecation diary. Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic (health-related) quality of life ((HR)QOL), and costs at 6 months. Furthermore, cost-effectiveness and budget-impact will be estimated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An average defecation frequency (DF) of <3 per week based on a 3-week defecation diary (patient-reported)
- •Meet at least one other criterion of the Rome-IV criteria for idiopathic constipation based on the 3-week defecation diary (1)
- •Refractory to conservative treatment
- •Age: 14-80 years
- •Slow-transit constipation
- •(1) Rome-IV criteria for idiopathic constipation:
- •Straining during ≥25% of defecations
- •Lumpy or hard stools in ≥25% of defecations
- •Sensation of incomplete evacuation for ≥25% of defecations
- •Sensation of anorectal obstruction/blockage for ≥25% of defecations
- •Manual manoeuvres to facilitate ≥25% of defecations
排除标准
- •Obstructed outlet syndrome (objectified by defeacography)
- •Irritable bowel syndrome (Rome-IV criteria for irritable bowel syndrome)
- •Congenital or organic bowel pathology
- •Rectal prolapse
- •Anatomical limitations preventing placement of an electrode
- •Skin and perineal disease with risk of infection
- •Previous large bowel/rectal surgery
- •Coexisting neurological disease
- •Significant psychological co-morbidity as assessed subjectively by the investigator
- •Being or attempting to become pregnant during study follow-up
结局指标
主要结局
Treatment success at 6 months
时间窗: 6 months
Treatment success is defined as an average defecation frequency of ≥ 3 a week based on a patient-reported defecation diary over a period of 3 weeks
次要结局
- Defecation frequency(1 and 3 months)
- Fatigue(Baseline, 1, 3 and 6 months)
- Proportion of patients with a 50% reduction in the proportion of defecations with straining(Baseline, 1, 3 and 6 months)
- Constipation severity(Baseline, 1, 3 and 6 months)
- Cost-effectiveness(6 months)
- Generic (HR)QOL(Baseline, 1, 3 and 6 months)
- Proportion of patients with a 50% reduction in the proportion of defecations with a sense of incomplete evacuation(Baseline, 1, 3 and 6 months)
- Resource use/costs(Baseline, 3 and 6 months)
- Budget-impact(6 months)
- Constipation-specific (health-related) quality of life ((HR)QOL)(Baseline, 1, 3 and 6 months)
- Adverse events/complications(Baseline, 1, 3 and 6 months)