RECURRENCE AFTER SURGERY FOR DUPUYTREN'S DISEASE: A RANDOMISED CONTROLLED TRIAL WITH DOUBLE BLINDING, COMBINING SEGMENTAL FASCIECTOMY WITH PLACEBO OR WITH NEO-ADJUV ANT ORAL TAMOXIFEN

Prospective randomised double-blind study on the influence of tamoxifen (a synthetic non­ steroidal anti-estrogen known to modulate the production of TGF beta and its influence on fibroblast function) on the healing process and the recurrence and/or extension of Dupuytren's disease after subtotal fasciectomy in high risk patients, graded 4 or more according to the scale of Abe, with a follow-up of 2 years after surgery (with unblinded extension to 5 years follow-up). The protocol was made up according to the CONSORT standards. The rationale is that tamoxifen has shown its ef iciency on fibroblast activity in vitro and in vivo. Clinical research was the main purpose of this study. A significant improvement in outcome was found, with a relative improvement of goniometric correction as measured by the Tubiana index, of 93% with tamoxifen and 61% with placebo. Also, visual analogue scales for satisfaction sho-wed an improvement in the tamoxifen group of 26%, compared to 6% in the placebo group. This study shows that neo-adjuvant use of tamoxifen can improve the surgical outcome of segmental fasciectomy in Dupuytren 's disease in patients with a high diathesis. The requirements put forward by the Declaration of Helsinki are respected. Study was approved by the Ethics Committee of the University Hospitals, KU Leuven IRB (OG032) nmbr ML 3936 on January 8th 2007. Acknowledgments. The first author wishes to thank Professor Dr M Hoogmartens for his help in the development, financing and organisation of this study.