Background and Aims:
Anal fistula plug AFP is a bioabsorbable bioprosthesis used in ano-perineal fistula treatment. We aimed to assess efficacy and safety of AFP in fistulising ano-perineal Crohn’s ...disease FAP-CD.
Methods:
In a multicentre, open-label, randomised controlled trial we compared seton removal alone control group with AFP insertion AFP group in 106 Crohn’s disease patients with non- or mildly active disease having at least one ano-perineal fistula tract drained for more than 1 month. Patients with abscess collection ≥ 3mm on magnetic resonance imaging or recto-vaginal fistulas were excluded. Randomisation was stratified in simple or complex fistulas according to AGA classification. Primary end point was fistula closure at Week 12.
Results:
In all, 54 patients were randomised to AFP group control group 52. Median fistula duration was 23 10–53 months. Median Crohn’s Disease Activity Index at baseline was 81 45–135. Fistula closure at Week 12 was achieved in 31.5% patients in the AFP group and in 23.1 % in the control group (relative risk RR stratified on AGA classification: 1.31; 95% confidence interval: 0.59–4.02; p = 0.19). No interaction in treatment effect with complexity stratum was found; 33.3% of patients with complex fistula and 30.8% of patients with simple fistula closed the tracts after AFP, as compared with 15.4% and 25.6% in controls, respectively RR of success = 2.17 in complex fistula vs RR = 1.20 in simple fistula; p = 0.45. Concerning safety, at Week 12, 17 patients developed at least one adverse event in the AFP group vs 8 in the controls p = 0.07.
Conclusion:
AFP is not more effective than seton removal alone to achieve FAP-CD closure.
Summary Hemorrhoids are a common medical problem that is often considered as benign. The French Society of Colo-Proctology ( Société nationale française de colo-proctologie SNFCP) recently revised ...its recommendations for the management of hemorrhoids (last issued in 2001), based on the literature and consensual expert opinion. We present a short report of these recommendations. Briefly, medical treatment, including dietary fiber, should always be proposed in first intention and instrumental treatment only if medical treatment fails, except in grade ≥ III prolapse. Surgery should be the last resort, and the patient well informed of the surgical alternatives, including the possibility of elective ambulatory surgery, if appropriate. Postoperative pain should be prevented by the systematic implementation of a pudendal block and multimodal use of analgesics.
Résumé
Des recommandations européennes concernant le traitement de la maladie de Verneuil ont été publiées récemment. Le traitement fait appel en première intension aux antibiotiques, mais en cas ...d’échec, les anti-TNF, et en particulier l’adalimumab, sont indiqués.
PDF
