Trial reportInternational journal of colorectal disease2018
Sacral neuromodulation versus personalized conservative treatment in patients with idiopathic slow-transit constipation: study protocol of the No.2-trial, a multicenter open-label randomized controlled trial and cost-effectiveness analysis.
Trial report in International journal of colorectal disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02961582 (Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation Refractory to Conservative Treatments
Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- Treatments for intractable constipation in childhood.The Cochrane database of systematic reviews · 2024Pooled it
- Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.Health technology assessment (Winchester, England) · 2024Pooled it
- Stapled trans-anal rectal resection can improve constipation symptoms and inflammatory reaction of patients with outlet obstructive constipation.American journal of translational research · 2021Article
- Comparison of long-term outcome of sacral nerve stimulation for constipation and faecal incontinence with focus on explantation rate, additional visits, and patient satisfaction.Techniques in coloproctology · 2020Article
- Sacral nerve stimulation in slow-transit constipation: effectiveness at 5-year follow-up.International journal of colorectal disease · 2019Article
- Sacral nerve stimulation for constipation: long-term outcomes.Techniques in coloproctology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.