An observational study in Constipation and Surgery, sponsored by Maastricht University Medical Center. Completed at 2 sites in Netherlands. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Maastricht University Medical Center · Observational
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).
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 23 is below the median of 100 across 129 observational studies indexed under Constipation.
Browse Constipation studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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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:
Slow-transit constipation
(1) Rome-IV criteria for idiopathic constipation:
Exclusion Criteria:
Device: Sacral Neuromodulation
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.
Also known as: Medtronic Interstim Therapy System
Treatment success at 6 months
Treatment success is defined as an average defecation frequency of ≥ 3 a week based on a patient-reported defecation diary over a period of 3 weeks
Time frame: 6 months
Complications/adverse events
Reported by the clinician in a case report form (CRF)
Time frame: 6 months
Proportion of patients with a 50% reduction in the proportion of defecations with straining
The proportion of defecations with straining is derived from the data in the 3 week defecation diary. The reported proportion of defecations with straining is compared with the proportion of defecations with straining at baseline. Patients are divided in two groups: 1) ≥50% reduction in the proportion of defecations with straining and 2) \<50% reduction in the proportion of defecations with straining. In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.
Time frame: Baseline, 1, 3 and 6 months, (12 months)
Proportion of patients with a 50% reduction in the proportion of defecations with a sense of incomplete evacuation
The proportion of defecations with a sense of incomplete evacuation is derived from the data in the 3 week defecation diary. The reported proportion of defecations with a sense of incomplete evacuation is compared with the proportion of defecations with a sense of incomplete evacuation at baseline. Patients are divided in two groups: 1) ≥50% reduction in the proportion of defecations with a sense of incomplete evacuation and 2) \<50% reduction in the proportion of defecations with a sense of incomplete evacuation. In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.
Time frame: Baseline, 1, 3 and 6 months, (12 months)
Constipation severity
Displayed with the score from the Wexner constipation score (WCS). In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.
Time frame: Baseline, 1, 3 and 6 months, (12 months)
Generic (HR)QOL
Displayed with the score from the EQ-5D-5L. In patients who still have the pacemaker at 6 months, outcomes are als measured 12 months after inclusion to monitor the longer term effectiveness and safety of SNM.
Time frame: Baseline, 1, 3 and 6 months, (12 months)
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center