Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict (PETER registry)

August 13, 2025 updated by: Gerrit A Schubert

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Stefanie Pflugi
Phone Number: +41628389203
Email: nro@ksa.ch

Study Locations

Germany
- NRW
  - Aachen, NRW, Germany, 52074
    - Dept. of Neurosurgery, RWTH Aachen University Hospital, RWTH Aachen University
    - Contact:
      
      Hans Clusmann, Univ.-Prof. Dr. med.
      
      Phone Number: +49 241 8088481
      
      Email: hclusmann@ukaachen.de
Switzerland
- Aargau
  - Aarau, Aargau, Switzerland, 5001
    - Dept. of Neurosurgery, Cantonal Hospital Aarau
    - Contact:
      
      Stefanie Pflugi, PhD
      
      Phone Number: +41 62 838 2778
      
      Email: stefanie.pflugi@ksa.ch
    - Principal Investigator:
      
      Gerrit A Schubert, MD
    - Sub-Investigator:
      
      Debora Cipriani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Study cohort will be selected from local Department of Neurosurgery of participating hospitals

Description

Inclusion Criteria:

suspected neurovascular conflict
signed consent for further use of routine clinical data as accepted by local regulations

Exclusion Criteria:

refusal of further use of routine clinical data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief after surgical treatment Time Frame: From enrolment to last follow-up 5 yrs after surgery	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.	From enrolment to last follow-up 5 yrs after surgery
Face specific pain relief after surgical treatment Time Frame: From enrolment to last follow-up 5 yrs after surgery	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.	From enrolment to last follow-up 5 yrs after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications Time Frame: three months after index surgery	any complications directly attributable to the surgical intervention	three months after index surgery
Need for additional treatment Time Frame: 5 years after index surgery	rate of patients having to undergo additional surgery / intervention / medication after microvascular decompression	5 years after index surgery
Patient satisfaction Time Frame: 5yrs after index surgery	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.	5yrs after index surgery
Effect of surgical treatment on quality of life Time Frame: 5 years after index surgery	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.	5 years after index surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerrit A Schubert

Collaborators

NeuroResearchOffice at Cantonal Hospital Aarau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2033

Study Registration Dates

First Submitted

August 5, 2025

First Submitted That Met QC Criteria

August 13, 2025

First Posted (Actual)

August 21, 2025

Study Record Updates

Last Update Posted (Actual)