A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial)

Eveline R.Y. Scheerders, Simone K. van der Velden, members of the SAPTAP group , Lucas M.A. Goossens, Sterre A.S. Hamann, Marianne G.R. de Maeseneer, Wendy S.J. Malskat, Linda de Mik, Tamar E.C. Nijsten, Renate R. van den Bos*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

6 Citations (Scopus)
30 Downloads (Pure)

Abstract

Background: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP. Methods: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success. Results: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP. Conclusion: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months.

Original languageEnglish
Pages (from-to)333-342
Number of pages10
JournalThe British journal of surgery
Volume110
Issue number3
DOIs
Publication statusPublished - 1 Mar 2023

Bibliographical note

Funding Information:
This study was funded by ZonMw (https://www.zonmw.nl). ZonMw had no role in the study design, data collection, analysis and interpretation of the data, writing of the report, and in the decision to submit the article for publication.

Publisher Copyright:
© The Author(s) 2022.

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