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Healing and functional outcomes after treatment of high anal fistula with a modified anal fistula plug: A Prospective Cohort Study

clinical-trials
gastroenterology-and-hepatology
surgery-and-surgical-specialties

Abstract

Background. To evaluate whether a modified anal fistula plug combined with a drainage seton can improve postoperative pain and 12-month healing rates, and to assess its effects on healing time, recurrence, bowel-function recovery, and other outcomes.
Methods. We conducted a single-center comparative cohort study at West China Hospital, including 140 patients with cryptoglandular anal fistula treated between January 2022 and December 2024. Patients were categorized by whether they received the anal fistula plug group (AFP) or not. Both groups followed our institution-specific postoperative pathway combining Chinese herbal fumigation with a protocolized recovery bundle.
Results. Baseline clinical characteristics were comparable between groups. Compared with contrast group, the AFP group showed faster postoperative recovery, with lower early postoperative pain and a shorter median time to healing. Functional recovery and overall clinical effectiveness were also higher early after surgery. At 12 months, overall effectiveness was similar between groups and recurrence did not differ significantly. Subgroup analysis suggested a greater acceleration of healing in patients with longer preoperative disease duration (≈45–365 days).
Conclusions. The modified AFP with drainage seton facilitates early recovery, significantly reduces postoperative pain, and shortens time to healing without increasing costs or hospital stay. Over 12 months, long-term efficacy and safety are comparable to conventional treatment, supporting the plug as a sphincter-preserving, cost-conscious alternative.
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