Abstract
PurposeThe evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment.MethodsThis study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Patients with obstructed outlet, irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, β = 0.80, 30% difference in success). Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. Long-term costs and effectiveness will be estimated by a decision analytic model. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic.ConclusionsThe results of this trial will be used to make a final decision regarding reimbursement of SNM from the Dutch Health Care Package in this patient group.Trial registrationThis trial is registered at clinicaltrials.gov, identifier NCT02961582, on 12 October 2016.
Highlights
Functional constipation (FC) is a functional bowel disorder with predominating symptoms of difficult, infrequent, or incomplete defecation, defined by the Rome-IV criteria [1, 2]
Besides the Cochrane review, the Dutch Health Care Institute published a report stating that there is insufficient evidence of high methodological quality to conclude that sacral neuromodulation (SNM) compared to conservative treatment is effective in slow-transit constipation [26]
This paper describes the study protocol of the No.2-trial assessing theeffectiveness of SNM in patients with idiopathic slow-transit constipation refractory to conservative treatments
Summary
This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, β = 0.80, 30% difference in success). Sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic
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