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

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.

      Study design: A prospective cohort study with one group. This study is conducted next to a
      randomized controlled clinical trial (RCT) on 'the effectiveness and cost-effectiveness of
      sacral neuromodulation in patients with idiopathic slow-transit constipation refractory to
      conservative treatments' (for more information ClinicalTrial.gov ID: NCT02961582). This RCT
      is part of a temporary reimbursement arrangement, called conditional reimbursement of health
      care (in Dutch: Voorwaardelijke Toelating) of the National Health Care Institute
      (Zorginstituut Nederland). As part of this arrangement, the Ministry of Health, Welfare and
      Sports requires that SNM remains available for eligible patients during the conditional
      reimbursement period, also when inclusion of the RCT has ended. Furthermore, the Ministry
      requires that patients who received personalized conservative treatment in the RCT (control
      group), are offered SNM after completion of their follow-up of 6 months. As a result, the
      National Health Care Institute requires that the patients who receive SNM outside the RCT are
      included in a prospective cohort study to be able to collect data on them.

      Aim: The aim of this prospective cohort study is to collect more (but uncontrolled)
      information regarding the safety and effectiveness of SNM.

      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, the pacemaker will be removed and patients
      receive conservative treatment.

      Main study parameters/endpoints: The primary outcome is treatment success at 6 months,
      defined as an average DF of ≥3 a week according to a 3-week defecation diary and safety.
      Secondary outcomes are straining, sense of incomplete evacuation, constipation severity and
      generic (health-related) quality of life ((HR)QOL).
    


Intervention name(s): Sacral Neuromodulation
Intervention type(s): Device
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 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.
Other intervention name(s): Medtronic Interstim Therapy System
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population consists of adolescents (14-17 years) and adults (18-80 years) with
        idiopathic slow-transit constipation refractory to conservative treatment. As data
        regarding this population is limited it is virtually impossible to provide precise numbers
        of this patient population. However, some numbers are known:

          -  Average prevalences of idiopathic constipation of 16% and 19.2% are reported in Europe

          -  Of all patients treated for constipation, 5.6% is treated at the hospital

          -  It is estimated that 1% of the constipation patients who are treated with conservative
             treatment in hospitals, are unresponsive and are eligible for sacral neuromodulation

          -  Over the last 6 years, annually, on average, 25 patients were treated with SNM at the
             Maastricht UMC+ and the Groene Hart Ziekenhuis Gouda
      
Keywords: Sacral neuromodulation; Constipation; Slow-transit constipation; Surgery; Colorectal surgery; Cost-effectiveness; Quality of life