Abstract
Introduction: Transsphincteric anal fistula remains a challenging problem for both surgeons and patients. Aggressive treatments are associated with high risk of incontinence, while minimally invasive methods have a higher recurrence rate. The minimally invasive vacuum therapy has also shown superiority to other surgical methods in the treatment of upper and lower gastrointestinal tract defects. In this study, we used a porcine model to test vacuum therapy as an innovative approach in the treatment of transsphincteric anal fistula. Methods: Three Pigs (Sus Scrofa Domesticus type) underwent a surgical creation of 4 iatrogenic transsphincteric anal fistulas in localizations 2, 5, 8 and 11 o’clock in supine position. After a period of 1 month, MRI confirmed the fistula formation. The 12 established fistulas were divided into 3 Groups. Group 1 (6/12) underwent vacuum therapy treatment. Group 2 (3/12) were left with a silicone drain in situ as positive control and Group 3 (3/12) were left untreated as negative control. The treatment phase lasted 18+/-3 days. Several MRIs were done to monitor the healing process. After 4 weeks of surveillance, euthanasia and en-bloc excision of the anorectum were performed for histopathological examination. Results: All treated fistulas completely healed macroscopically. The radiological and histopathological examinations of the vacuum treated tracts confirmed the tract’s closure with evidence of less inflammatory reactions in comparison with those in the control groups. Conclusion: Endofistula vacuum therapy treatment of transsphincteric anal fistula is feasible and safe. Therefore, we are planning a prospective multicenter clinical trial.
Published Version
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