Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation
Condition: Constipation; Surgery
MeSH terms: Constipation
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Sacral Neuromodulation; Personalized Conservative Treatment
Intervention type(s): Device; Other
Intervention description(s): SNM starts with a screening phase. In this phase a tined lead is inserted into the third sacral foramen and attached to an external stimulator, after which the patient enters a four-week stimulation test period. If the screening phase is successful (defecation frequency (DF) ≥3 a week), the external stimulator is changed for a pacemaker that is implanted in the buttocks. If the screening phase is unsuccessful (DF <3 a week), the lead is explanted.
Patients in the intervention group are asked to limit the use of additional conservative treatments for constipation (such as laxatives and colonic irrigation) to what is necessary to relieve (the most severe) complaints. What is necessary to relieve complaints is determined by the patient.; The control group will receive the best and least invasive alternative treatment, which is personalized conservative treatment (PCT). PCT includes, a combination of laxative/medication use and/or colonic irrigation, depending on the preferences of the patient. Use of PCT will be documented.
Other intervention name(s): Medtronic Interstim Therapy System; Care as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sacral neuromodulation; Constipation; Slow-transit constipation; Surgery; Colorectal surgery; Cost-effectiveness; Quality of life