Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46623
Enrollment
50
Registered
2018-06-04
Start date
2018-10-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Costo-Clavicular Compression Syndrome (CCCS) thoracic outlet syndrome

Interventions

Patients with a diagnosis of NTOS will be randomized into TOD versus conservative treatment. The group with conservative treatmentwill receive surgical therapy after 3 months if complaints persist.

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary endpoint will be the DASH SCORE. This endpoint will be measured with the DASH questionnaire (Disability of the Arm, Shoulder and Hand)

Secondary

MeasureTime frame
Secondary endpoint will be the score on the CBSQ, VAS scale and SF 12. This endpoint will be measured with the CBSQ questionnaire (Cervical-Brachial Symptoms Questionnaire), VAS scale (Visual Analogue Scale for Pain) and SF 12 (Short Form 12 questionnaire)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)