Constipation slow-transit constipation
Conditions
Interventions
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 st
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: - An average defecation frequency (DF) of
Exclusion criteria
Exclusion criteria: * Obstructed outlet syndrome (objectified by defeacography) * Irritable bowel syndrome (Rome-IV criteria for irritable bowel syndrome) * Congenital or organic bowel pathology * Rectal prolapse * Anatomical limitations preventing placement of an electrode * Skin and perineal disease with risk of infection * Previous large bowel/rectal surgery * Stoma * Coexisting neurological disease * Significant psychological co-morbidity as assessed subjectively by the investigator * Being or attempting to become pregnant during study follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome is treatment success. Patients with an average defecation frequency (DF) of *3 a week are considered successfully treated. Patients with an average DF of | — |
Secondary
| Measure | Time frame |
|---|---|
| * Proportion of patients with a 50% reduction in the proportion of defecations with straining, derived from the defecation diary. * Proportion of patients with a 50% reduction in the proportion of defecations with a sense of incomplete evacuation, derived from the defecation diary * Constipation severity, displayed with the score from the Wexner constipation score (WCS). * Fatigue, displayed with the score from the *Verkorte vermoeidheidsvragenlijst* (VVV) * Constipation-specific (health-related) quality of life ((HR)QOL), displayed with the score from the Patient Assessment of Constipation * Quality of Life (PAC-QOL) questionnaire. * Generic (HR)QOL, measured with the EQ-5D-5L, the ICECAP-A (adults) and the KIDSCREEN-27 (adolescents) * Adverse events/complications, reported by the clinician in a case report form (CRF) * Resource use/costs from a societal and health care perspective * Cost-effectiveness from a societal and health care perspective * Budget-impact from a societal, health care and health care insurance perspective | — |
Countries
Netherlands
Outcome results
None listed