Clinical response and sustainability of treatment with temperature- controlled radiofrequency energy (Secca) in patients with faecal incontinence: 3 Years follow-up

摘要

Background: Controlled delivery of radio frequent energy (Secca) has been suggested as treatment for faecal incontinence (FI). Objective: The objective of the study is to evaluate clinical response and sustainability of Secca for FI. Design: This is a prospective cohort study. Patients This study involved patients who had failed full conservative management for FI. Interventions: This study was performed between 2005 and 2010. Main outcome measures: FI was scored using the Vaizey score (VS). A clinically significant response to Secca was defined as ≥50% reduction in incontinence score. Impact of FI on quality of life (QOL) was measured using the FIQL. Data was obtained at baseline, at 6 months and at 1 and 3 years. Anal endosonography and anal manometry were performed at 3 months and compared to baseline. Results: Thirty-one patients received Secca. During follow-up, 5/31 (16%), 3/31 (10%) and 2/31 (6%) of patients maintained a clinically significant response after the Secca procedure. Mean VS of all patients was 18 (SD 3), 14 (SD 4), 14 (SD 4) and 15 (SD 4), at baseline, 6 months and 1 and 3 years. No increases in anorectal pressures or improvements in rectal compliance were found. Coping improved between baseline and t=6 months. No predictive factors for success were found. Limitations: This is a non-randomised study design. Conclusion: This prospective non-randomised trial showed disappointing outcomes of the Secca procedure for the treatment of FI. The far minority of patients reported a clinically significant response of seemingly temporary nature. Secca might be valuable in combination with other interventions for FI, but this should be tested in strictly controlled randomised trials.