Comparative Study Between Regular Seton and GLUBRAN® Coated Seton in the Management of High Anal Fistula (Novel Technique)

High anal fistula is a challenging anorectal disorder characterized by an abnormal communication between the anal canal and the perianal skin that involves a significant portion of the anal sphincter complex. Patients with high anal fistulas commonly present with persistent perianal pain, recurrent abscess formation, purulent discharge, local irritation, and a substantial reduction in quality of life. These fistulas are considered complex because of their anatomical relationship with the anal sphincter muscles and the increased risk of postoperative continence impairment following surgical treatment. Consequently, the ideal management strategy should achieve complete eradication of the fistula tract while preserving sphincter function and minimizing the risk of recurrence.

The cutting seton technique has long been used as a sphincter-preserving surgical approach for the management of high anal fistulas. The procedure involves placement of a seton through the fistula tract, allowing gradual division of the sphincter muscle while promoting fibrosis and controlled healing. Although this technique has demonstrated satisfactory healing rates in numerous studies, concerns remain regarding postoperative pain, prolonged healing time, recurrence, local infection, and varying degrees of fecal incontinence. Therefore, ongoing efforts have focused on identifying modifications that may improve clinical outcomes while maintaining the effectiveness of the procedure.

GLUBRAN® is a synthetic cyanoacrylate-based surgical adhesive that has been used in multiple surgical specialties because of its adhesive, hemostatic, sealing, and bacteriostatic properties. Experimental and clinical evidence suggests that cyanoacrylate-based materials may reduce bacterial colonization, attenuate local inflammatory responses, provide mechanical support to healing tissues, and promote tissue repair. Coating a cutting seton with GLUBRAN® may therefore enhance the therapeutic effect of the procedure by reducing local infection, minimizing tissue irritation, facilitating wound healing, and potentially decreasing postoperative complications. Despite these theoretical advantages, there is currently limited clinical evidence directly comparing GLUBRAN®-coated cutting setons with conventional cutting setons in the management of high anal fistulas.

This study is designed as a prospective, randomized controlled clinical trial conducted at Cairo University Hospitals to evaluate the efficacy and safety of GLUBRAN®-coated cutting setons compared with conventional cutting setons in adult patients with high anal fistulas. Eligible participants will include patients aged 18 years or older with high trans-sphincteric, suprasphincteric, extrasphincteric, or otherwise complex anal fistulas confirmed by clinical examination and magnetic resonance imaging (MRI) fistulography. Patients with Crohn's disease, tuberculosis, malignancy-associated fistulas, radiation-induced fistulas, active perianal abscesses, or significant uncontrolled medical conditions that may interfere with wound healing will be excluded.

Following enrollment, participants will be randomly allocated in a 1:1 ratio to one of two treatment groups. Patients assigned to the control group will undergo conventional cutting seton placement using silk suture material. Patients assigned to the intervention group will undergo placement of a silk cutting seton coated with GLUBRAN® surgical adhesive before insertion through the fistula tract. All procedures will be performed according to standardized operative techniques, and all participants will receive standardized postoperative care, including analgesia, antibiotic therapy when indicated, and scheduled outpatient follow-up.