Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial.
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
10 Jun 2022
10 Jun 2022
Historique:
received:
10
01
2022
accepted:
31
05
2022
entrez:
10
6
2022
pubmed:
11
6
2022
medline:
15
6
2022
Statut:
epublish
Résumé
Treatment of superficial venous reflux has been shown to improve ulcer healing time and reduce the risk of ulcer recurrence. Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins. TIRS has been shown to be successful and in our experience is the option preferred by many patients, when offered as an alternative to axial ablation (AA). To determine if the proportion of ulcers healed within 6 months of endovenous treatment differs between patients undergoing AA of varicose veins or TIRS by peri-ulcer foam sclerotherapy. AAVTIRS is an assessor-blinded randomised controlled trial. Patients will be recruited from a dedicated ulcer clinic in Roscommon University Hospital and from the vascular surgical clinics in University Hospital Galway. All patients attending the ulcer clinic will be screened for eligibility. Random computer-generated sequence is stratified by ulcer size. Allocation will be concealed using sealed opaque envelopes. Assessors reviewing wounds at follow -p visits will be blinded to patient allocation. The proportion of ulcers healed within 6 months of enrolment. This will be the first time that TIRS has been evaluated with a properly powered randomised trial in the setting of venous ulcer management. Streamlining the management of venous ulcers has broad health economic benefits. If it is found that TIRS is superior or non-inferior to AA, then a less expensive, less invasive injection can be offered as an alternative to AA in an attempt to encourage the healing of venous ulcers. If AA is found to be superior to TIRS, then this would suggest that all patients undergoing ablation in the management of venous ulcers should have their superficial reflux fully treated, building on the evidence of the EVRA trial. ClinicalTrials.gov NCT04484168. Registered on 23 July 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Treatment of superficial venous reflux has been shown to improve ulcer healing time and reduce the risk of ulcer recurrence. Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins. TIRS has been shown to be successful and in our experience is the option preferred by many patients, when offered as an alternative to axial ablation (AA).
AIM
OBJECTIVE
To determine if the proportion of ulcers healed within 6 months of endovenous treatment differs between patients undergoing AA of varicose veins or TIRS by peri-ulcer foam sclerotherapy.
METHODS
METHODS
AAVTIRS is an assessor-blinded randomised controlled trial. Patients will be recruited from a dedicated ulcer clinic in Roscommon University Hospital and from the vascular surgical clinics in University Hospital Galway. All patients attending the ulcer clinic will be screened for eligibility.
RANDOMISATION
METHODS
Random computer-generated sequence is stratified by ulcer size. Allocation will be concealed using sealed opaque envelopes.
BLINDING
METHODS
Assessors reviewing wounds at follow -p visits will be blinded to patient allocation.
PRIMARY ENDPOINT
METHODS
The proportion of ulcers healed within 6 months of enrolment.
DISCUSSION
CONCLUSIONS
This will be the first time that TIRS has been evaluated with a properly powered randomised trial in the setting of venous ulcer management. Streamlining the management of venous ulcers has broad health economic benefits. If it is found that TIRS is superior or non-inferior to AA, then a less expensive, less invasive injection can be offered as an alternative to AA in an attempt to encourage the healing of venous ulcers. If AA is found to be superior to TIRS, then this would suggest that all patients undergoing ablation in the management of venous ulcers should have their superficial reflux fully treated, building on the evidence of the EVRA trial.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT04484168. Registered on 23 July 2020.
Identifiants
pubmed: 35689289
doi: 10.1186/s13063-022-06440-4
pii: 10.1186/s13063-022-06440-4
pmc: PMC9188187
doi:
Banques de données
ClinicalTrials.gov
['NCT04484168']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
483Informations de copyright
© 2022. The Author(s).
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