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.

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