OBJECTIVE: This prospective, two-centre study was designed to evaluate long-term outcomes when using a collagen plug to treat cryptoglandular anal fistulae. MATERIALS AND METHOD: Over 3 years, 60 consecutive patients with cryptoglandular fistulae were treated using an anal fistula plug by experienced surgeons. Preoperative, postoperative and follow-up data were collected in a dedicated database. Success was defined as the closure of all fistula openings and the absence of discharge. Faecal incontinence scores were administered at baseline and at 6 months follow-up. RESULTS: Eleven patients had multiple fistula tracts. All fistulae treated in this series were classified as complex. Seventeen fistulae were anterior tracts in females, and the remaining tracts were trans-sphincteric in nature. Thirty-eight tracts were recurrent. Mean operative time was 26 ± 10 min. No major complications, active sepsis or mortality were observed. Success rate with a mean follow-up of 13 months was 60% of patients and 70% of tracts. Mean time for recurrence was 5.7 months. Two recurrent patients were successfully treated with a redo plug procedure, and five were successfully closed with a post-plug fistulotomy, leading to a global 72% success rate without continence impairment. Of the patients with a minimum follow-up of 6 months (mean, 18.5 months; range, 6-34 months), 29 in 32 (90.6%) were healed at final evaluation. In these patients, the mean preoperative CCF incontinence score was 0.73. This was reduced to 0.14 at 6-month follow-up. The mean reduction of CCF incontinence score was -0.6 (95% CI, 1.3 to -0.1; p = 0.01). CONCLUSION: Fistula tract treatment with the anal fistula plug is a safe and viable surgical option that should be offered to complex fistula patients. The reasons and risk factors for recurrence remain to be explored.
OBJECTIVE: This prospective, two-centre study was designed to evaluate long-term outcomes when using a collagen plug to treat cryptoglandular anal fistulae. MATERIALS AND METHOD: Over 3 years, 60 consecutive patients with cryptoglandular fistulae were treated using an anal fistula plug by experienced surgeons. Preoperative, postoperative and follow-up data were collected in a dedicated database. Success was defined as the closure of all fistula openings and the absence of discharge. Faecal incontinence scores were administered at baseline and at 6 months follow-up. RESULTS: Eleven patients had multiple fistula tracts. All fistulae treated in this series were classified as complex. Seventeen fistulae were anterior tracts in females, and the remaining tracts were trans-sphincteric in nature. Thirty-eight tracts were recurrent. Mean operative time was 26 ± 10 min. No major complications, active sepsis or mortality were observed. Success rate with a mean follow-up of 13 months was 60% of patients and 70% of tracts. Mean time for recurrence was 5.7 months. Two recurrent patients were successfully treated with a redo plug procedure, and five were successfully closed with a post-plug fistulotomy, leading to a global 72% success rate without continence impairment. Of the patients with a minimum follow-up of 6 months (mean, 18.5 months; range, 6-34 months), 29 in 32 (90.6%) were healed at final evaluation. In these patients, the mean preoperative CCF incontinence score was 0.73. This was reduced to 0.14 at 6-month follow-up. The mean reduction of CCF incontinence score was -0.6 (95% CI, 1.3 to -0.1; p = 0.01). CONCLUSION:Fistula tract treatment with the anal fistula plug is a safe and viable surgical option that should be offered to complex fistulapatients. The reasons and risk factors for recurrence remain to be explored.
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