2007 - SECCA CLINICAL Temperature controlled radiofrequency energy (Secca) to the anal canal for the treatment of fecal incontinence: pilot seems promising
R. F. Felt-bersma; C. J. Mulder
European Journal of Gastroenterology & Hepatology. 2007, 19:575–580
INTRODUCTION Fecal incontinence is a devastating complaint. Even after conservative measures like diet adaptation, fibers and physiotherapy amajority of patients still has complaints. Few patients have a sphincter defect suitable for repair. Other emerging therapies like dynamic gracilis plasty or neuromodulation carry side effects and are not generally available partly due to financial restrictions. Temperature controlled radio frequency energy (RF), (Secca®) (equivalent to Stretta® of the esophagus) has shown promising results in the USA. The mode of action is not totally clear, local fibrosis seems the mode of action with possibly increased rectal sensitivity.
PATIENTS & METHODS We treated 11 females, mean age 61 years (49-73) with the Secca® procedure. Patients with diarrhea (defecation more than 3 x day), sphincter defects and relative anal stenosis were excluded. The procedure was performed under conscious sedation and local anesthesia. Oral antibiotics were given 8 hours before, at the procedure and 8 hours later. In 4 quadrants on 4 or 5 levels (depending upon length of the anus) RF was delivered with multiple needle electrodes. Laxatives were prescribed in case of hard stools first days after treatment. Patients were evaluated at 0, 6 weeks, 3 and 6 months. Anal endosonography was performed at 0 (before and after the procedure), after 6 weeks and 3 months. Anal manometry and rectal compliance measurement were performed at 0 and 3 months.
RESULTS At 3 months, 6 of 11 patients had an improvement (5 good, one slightly) and 5 none. The improvement persisted during follow up (6-9 months). At 3 months, the Vaizey score changed from 19 to 15 (p=0.056) and in the improved patients from 18,3 to 11,5 (p<0.001). The tests showed no change, there was a tendency of increased rectal sensitivity. Side effects were local hematoma (2), bleeding 3 days (1), pain persisting 2-3 weeks (4) and laxatives related diarrhea during 1-3 weeks (4). In conclusion, the Secca® procedure seems promising for patients with fecal incontinence with a persisting effect (so far follow up 6-9 months). Mild side effects are dominating the first 3 weeks, effect should be judged after 12 weeks. Financial reimbursing needs to be solved.