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

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Web of Science)

Abstract

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 (alpha = 0.05, beta = 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.

Original languageEnglish
Pages (from-to)493-501
Number of pages9
JournalInternational Journal of Colorectal Disease
Volume33
Issue number4
DOIs
Publication statusPublished - Apr 2018

Keywords

  • Sacral neuromodulation
  • Constipation
  • Quality of life
  • Cost-effectiveness
  • QUALITY-OF-LIFE
  • NERVE-STIMULATION
  • SURGICAL COMPLICATIONS
  • CONTROLLED CROSSOVER
  • ADOLESCENTS
  • CHILDREN
  • CLASSIFICATION
  • QUESTIONNAIRE
  • MODULATION
  • MANAGEMENT
  • Humans
  • Conservative Treatment
  • Constipation/economics
  • Sacrum/innervation
  • Sample Size
  • Cost-Benefit Analysis
  • Electric Stimulation Therapy/adverse effects
  • Gastrointestinal Transit/physiology
  • Cohort Studies

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