Surgical Thoracic Outlet decompression versus conservative approach for Patients with Neurogenic Thoracic Outlet Syndrome, a randomized controlled trial (STOPNTOS)

Recruiting

Conditions: Costo-Clavicular Compression Syndrome (CCCS)
thoracic outlet syndrome
10041543
10009720

Registration Number: NL-OMON46623

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

* High suspicion of NTOS with high level of impairment.
o The decision to refer a patient with NTOS for surgery is placed at the sole authority of the TOS multidisciplinary workgroup. Members of this workgroup are 2 dedicated vascular surgeons, 2 neurologists, 1 orthopedic surgeon, 3 physiotherapists, 2 radiologists, 3 anesthesiologists.
This decision is based on the reporting standards published by Illig et al. in 2016. If a patient fits the criteria postulated in the reporting standards, if the clinical suspicion is high, if the technical imaging (X-Ray, EMG, CT) is consistent, if the impairment for the patient is high and if there is consensus, only then patients are referred for TOD.
* Fit for surgery, at the discretion of the treating vascular surgeon and anesthesiologist.
* 18 years of age or older
* Dutch speaking patients

Exclusion Criteria

* Unfit for surgery, at the discretion of the treating vascular surgeon.
* Younger than 18 years of age
* Patients that do not speak Dutch or English.
* Patients with a history of TOD

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint will be the DASH SCORE. This endpoint will be measured with<br /><br>the DASH questionnaire (Disability of the Arm, Shoulder and Hand) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint will be the score on the CBSQ, VAS scale and SF 12.<br /><br>This endpoint will be measured with the CBSQ questionnaire (Cervical-Brachial<br /><br>Symptoms Questionnaire), VAS scale (Visual Analogue Scale for Pain) and SF 12<br /><br>(Short Form 12 questionnaire) </p><br>