The main objective of this study is assessing the effectiveness of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. The secondary objectives are…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 <3 a week are considered not successfully treated. This is a
clinically relevant outcome, consistent with the internationally widely
accepted Rome-IV criteria for idiopathic constipation. DF will be measured
using a defecation diary (DD) over a period of 3 weeks (patient-reported).
Secondary outcome
* 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
Background summary
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
evidence regarding costs and cost-effectiveness in this patient group.
Study objective
The main objective of this study is assessing the effectiveness of SNM compared
to personalized conservative treatment (PCT) in patients with idiopathic
slow-transit constipation refractory to conservative treatment. The secondary
objectives are assessing the 1) costs, 2) cost-effectiveness and 3)
budget-impact of SNM compared to PCT.
Study design
An open-label pragmatic randomized controlled trial (RCT).
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.
The control intervention is PCT. This is the best and least invasive
alternative to SNM. PCT consists of medication and/or retrograde colonic
irrigation.
Study burden and risks
Currently, the mechanism of action of SNM is not fully elucidated. However, we
believe that this will not pose any extra risk on the subjects. All reported
complications of SNM were grade I to grade III complications (i.e. not
life-threatening). As PCT is equal to the care that patients received before
the start of the study, this control intervention will not pose any additional
risks on the participants. All outcomes are measured with questionnaires.
Hence, the patient burden of study participation is relatively small.
P Debyelaan 25
Maastricht 6229 HX
NL
P Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- An average defecation frequency (DF) of <3 per week based on a 3-week
defecation diary (patient-reported)
- Meet at least one other criterion of the Rome-IV criteria for idiopathic
constipation based on the 3-week defecation diary
- Resistant to conservative treatment (i.e. an average DF of <3 per week and
meet at least one other criterion of the Rome-IV criteria despite maximal
conservative treatment. This means that the patient must have been resistant to
the following treatments: lifestyle changes, laxatives, enemas and retrograde
colonic irrigation)
- Age: 14-80 years
- Slow-transit constipation
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02961582 |
| CCMO | NL57367.068.16 |