Sacral Neurostimulation for Inflammatory Bowel Disease, a Pilot Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23058

Enrollment

Registered

2017-05-10

Start date

2017-07-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease Ulcerative colitis Sacral neurostimulation Inflammatoire darmziekten Colitis ulcerosa Sacrale zenuwstimulatie.

Interventions

Sacral neurostimulation by electrode in oval foramen of S3

Eligibility

Inclusion criteria

Inclusion criteria: - distal colitis with refractory symptoms on enteral steroids - age >/= 18 years - endoscopic disease activity - informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
the feasibility of the use of SNS as a potential treatment for distal colitis in patients with inflammatory bowel disease	—

Secondary

Measure	Time frame
- 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	—

Contacts

Public ContactV.M.W.T. Klemann

Academisch Ziekenhuis Maastricht, Department of Surgery , Postbus 5800

victor.klemann@mumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)