Evaluating the efficacy of multi-incision and tube-dragging therapy combined with laser closure for high horseshoe-shaped anal fistula: Protocol of a prospective, randomized, controlled trial

• DOI: 10.1371/journal.pone.0307653
• Publication Date: 2024-09-27T17:27:16Z
• Authors: Min Yang; Zubing Mei; Qingming Wang; Ye Han; De Zheng
• Keywords: Clinical endpoint; Fecal Incontinence

Introduction High horseshoe-shaped anal fistula (HHAF) is a complicated and challenging condition that presents considerable obstacles in treatment. We are presently investigating novel surgical technique involving combination of multi-incision tube-dragging therapy, laser closure (MITD-LaC) for the management HHAF. Due to current scarcity rigorous evidence evaluating this approach, it essential perform well-designed randomized controlled trial compare effectiveness new method with incision thread-drawing therapy. Methods analysis This prospective, randomized, interventional study. After preliminary screening qualified outpatients, total 64 adult patients will be enrolled randomly allocated either MITD-LaC group or control (n = 32 per group). These receive The design aims allow robust comparison between two treatment modalities. primary endpoint wound healing time, while secondary endpoints include postoperative pain at 1, 3, 5 days (measured visual analogue scale), fecal incontinence score within 30 after operation Cleveland Clinic Florida score), occurrence complications 1 month surgery, quality life up six months postoperatively (evaluated by Quality Life Anal Fistula Questionnaire Score). Discussion study represents first short-term outcomes MITD-LaC, thereby aiming contribute high-quality guide clinical practice. Moreover, incorporates comprehensive outcome measures assessing both subjective objective dimensions. Because multidimensional assessment, offers promising potential broader application Consequently, obtaining more definitive authoritative through scientifically trials utmost importance further validating approach. Ethics dissemination have submitted protocol Committee, has been approved under ethical approval number 2021-1036-111-01. results disseminated peer-reviewed academic journals presentations professional conferences. Registration ChiCTR2100053556 .