|- candidate number||27185|
|- NTR Number||NTR6429|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2017|
|- Secondary IDs||NL60567.068.17 Toetsingonline ID|
|- Public Title||Sacral Neurostimulation for Inflammatory Bowel Disease, a Pilot Study|
|- Scientific Title||na|
|- hypothesis||Sacral neurostimulation can have a benificial effect on disease activity of inflammatory bowel disease in distal colitis. So sacral neurostimulation can be a additional therapy for inflammatory bowel disease.|
|- Healt Condition(s) or Problem(s) studied||Inflammatory bowel disease, Ulcerative Colitis, Suprastructure complications, Sacral neurostimulation|
|- Inclusion criteria||- distal colitis with refractory symptoms on enteral steroids|
- age >/= 18 years
- endoscopic disease activity
- informed consent
|- Exclusion criteria||- Previous rectal of sigmoid surgery|
- Presence of a stoma
- No or poor understanding of Dutch language
- Cognitive not able to provide required information in follow-up
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2017|
|- planned closingdate||1-nov-2018|
|- Target number of participants||10|
|- Interventions||Sacral neurostimulation by electrode in oval foramen of S3|
|- Primary outcome||the feasibility of the use of SNS as a potential treatment for distal colitis in patients with inflammatory bowel disease|
|- Secondary outcome||- disease activity and severity|
- Patient reported disease symptoms (PSCCAI)
- General health experience (EQ-5D-5L and SF-36)
- Histopathologic changes in biopsies
- Bowel wall integrity and permeability
- Bowel wall inflammation activity
- Patient reported quality of life
- Reduction of anti-inflammatory medication
- Side effects
- Costs of care
|- Timepoints||Prior to inclusion (T=0)|
3 weeks (T=1)
6 weeks (T=2)
3 months (T=3)
12 months (T=4)
|- Trial web site||na|
|- CONTACT FOR PUBLIC QUERIES||Drs. V.M.W.T. Klemann|
|- CONTACT for SCIENTIFIC QUERIES||Drs. V.M.W.T. Klemann|
|- Sponsor/Initiator ||Academisch Ziekenhuis Maastricht, Department of Surgery|
(Source(s) of Monetary or Material Support)
|Academisch Ziekenhuis Maastricht, Department of Surgery|
|- Brief summary||Rationale: Sacral neurostimulation has been proven an effective treatment for several conditions in the past three decades. Urinary and fecal incontinence and slow bowel transit are successfully treated with sacral neuromodulation. Recent insights suggest a potential beneficial effect of SNS on bowel integrity and bowel wall permeability. We hypothesize a reduction in IBD disease activity and symptoms after SNS in distal colitis.
Objective: The main objective is to investigate the effect feasibility of SNS for inflammatory bowel disease (ie do IBD patients accept and tolerate SNS as a treatment for their condition).
Of course we will as well investigate on changes disease activity and severity by a combination of parameters: endoscopic disease severity score, fecal calprotectin and serum CRP levels.
Besides we will look into: patient reported symptoms of distal colitis, bowel wall integrity and permeability, bowel wall inflammation, systemic parameters of inflammation, use of anti-inflammatory medication, quality of life, defecation profile, intestinal microbioma, side effects, costs.
Study design: Interventional pilot study
Study population: Patients with a distal (sigmoid or rectum) colitis with refractory symptoms on enteral corticosteroids (oral or enema), age > 18 years, adequate understanding of dutch language, no previous sigmoid or rectal surgery.
Intervention (if applicable): All patients will undergo implantation of a one-sided sacral electrode at the height of sacral foramen S3 under local of general anesthesia. Initially the electrode will be connected to an external pulsegenerator (pacemaker). After an evaluation period of 3-4 weeks if effects are positive an internal pacemaker will be installed under local or general anesthesia. In the case of negative effects or on patients request the electrode will be removed.
Main study parameters/endpoints: The main study parameter will be the feasibility of the SNS for IBD patients.
Next to the evaluation of this feasibility we will look into endoscopic disease severity score in combination with fecal calprotectin and serum CRP levels.
Next to these disease severity parameters we will also investigate: patient reported health related quality of life (HRQL) measured by Patient Simple Clinical Colitis Activity Index (PSCCAI) and EQ-5D-5L, bowel wall integrity and permeability, bowel wall inflammation, systemic parameters of inflammation, use of anti-inflammatory medication, quality of life, defecation profile, intestinal microbioma, side effects, costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
First it is imported to notice that patients with distal colitis often visit outpatient departments and regularly undergo endoscopic evaluation of their disease. Of course participation in this study increases the number of visits and examinations.
Prior to implantation all patients - and their disease severity - have to be evaluated. A sigmoidoscopy with biopsy of disease area has to be performed if not done in the last 2 months, with material for laboratory evaluation available
At baseline a series of questionnaires: PSCCAI, EQ-5D-5L and 36-item Short-Form Health Survey (SF-36) have to be filled in.
At 3 weeks, prior to internalization of electrodes the PSCCAI has to be filled in. At 6 weeks evaluation with PSCCAI. At 3 months control by sigmoidoscopy and questionnaires mentioned above. All questionnaires can be completed at home and send in by post or electronically.
Above mentioned procedures and questionnaires are a known burden on patients, but potential benefits are vast. If patients respond on the SNS they may do not need systemic medical therapy (anti-TNF-a or purinethol) with a diversity of side effects.
|- Main changes (audit trail)|
|- RECORD||10-mei-2017 - 28-jun-2017|