Skip to main content

22.02.2018 | Clinical Study Protocol | Ausgabe 4/2018 Open Access

International Journal of Colorectal Disease 4/2018

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

International Journal of Colorectal Disease > Ausgabe 4/2018
S. C. M. Heemskerk, A. H. Rotteveel, M. A. Benninga, C. I. M. Baeten, A. A. M. Masclee, J. Melenhorst, S. M. J. van Kuijk, C. D. Dirksen, S. O. Breukink
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s00384-018-2978-x) contains supplementary material, which is available to authorized users.



The 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.


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. 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.


The 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 registration

This trial is registered at clinicaltrials.​gov, identifier NCT02961582, on 12 October 2016.

Unsere Produktempfehlungen

e.Med Interdisziplinär


Mit e.Med Interdisziplinär erhalten Sie Zugang zu allen CME-Fortbildungen und Fachzeitschriften auf Zusätzlich können Sie eine Zeitschrift Ihrer Wahl in gedruckter Form beziehen – ohne Aufpreis.

e.Med Innere Medizin


Mit e.Med Innere Medizin erhalten Sie Zugang zu CME-Fortbildungen des Fachgebietes Innere Medizin, den Premium-Inhalten der internistischen Fachzeitschriften, inklusive einer gedruckten internistischen Zeitschrift Ihrer Wahl.

e.Med Chirurgie


Mit e.Med Chirurgie erhalten Sie Zugang zu CME-Fortbildungen des Fachgebietes Chirurgie, den Premium-Inhalten der chirurgischen Fachzeitschriften, inklusive einer gedruckten chirurgischen Zeitschrift Ihrer Wahl.

ESM 1 (PDF 238 kb)
Über diesen Artikel

Weitere Artikel der Ausgabe 4/2018

International Journal of Colorectal Disease 4/2018 Zur Ausgabe

Neu im Fachgebiet Chirurgie

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Chirurgie und bleiben Sie gut informiert – ganz bequem per eMail.