About this trial
The aim of the registry is a multicenter, prospective long-term data collection of patients suspected neurovascular conflict and referred for possible microvascular decompression (Jannetta procedure). The registry relies exclusively on routinely collected clinical data, which are gathered in a standardized and privacy-compliant manner as part of everyday clinical practice. By systematically compiling this information across multiple centers, valuable insights into the effectiveness, potential side effects, and long-term outcomes of this surgical treatment can be gained. The registry will serve as a foundation for future scientific analyses and is intended to help answer relevant research questions regarding the treatment of trigeminal neuralgia based on solid evidence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suspected neurovascular conflict
signed consent for further use of routine clinical data as accepted by local regulations
Disqualifiers
refusal of further use of routine clinical data
Trial population
Study cohort will be selected from local Department of Neurosurgery of participating hospitals
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pain relief after surgical treatment
Efficacy of microvascular decompression surgery, defined by the change in pain as assessed by the patient using the Visual Analog Scale (VAS) from 0 to 100 mm, with higher scores representing worse outcomes.
Face specific pain relief after surgical treatment
Efficacy of microvascular decompression surgery, defined by the change in facial pain and pain interference as assessed by the patient using the Brief Pain Inventory-Facial (BPI-Facial), with numerical scores ranging from 0 to 10, where higher scores represent worse outcomes.
Secondary outcomes
Surgical complications
any complications directly attributable to the surgical intervention
Need for additional treatment
rate of patients having to undergo additional surgery / intervention / medication after microvascular decompression
Patient satisfaction
Perceived benefit of surgery as determined by Patient global impression of change (PGIC) scores. The PGIC is a 7-point, patient-reported scale that captures an individual's overall perception of change in their condition. It ranges from "very much improved" to "very much worse," enabling patients to rate whether they feel their health has improved, remained the same, or declined.
Effect of surgical treatment on quality of life
Efficacy of microvascular decompression surgery as defined by change of Quality of Life Questionaire as measured by EQ-5D-5L. The EQ-5D-5L is a standardized, patient-reported outcome measure that assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from "no problems" to "extreme problems.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Gerrit A Schubert
Lead sponsor
Kantonsspital Aarau
Sponsor institution
NeuroResearchOffice at Cantonal Hospital Aarau
Collaborator
This trial is not recruiting at the moment. You can still explore other options: