Clinical study on the effectiveness and safety of loose combined cutting seton in the treatment of high perianal abscess: a randomized controlled trial protocol

Abstract

Background: High perianal abscess is an emergency in the anorectal department. It can result in longterm pain and a huge psychological burden to patients, and seriously affects the quality of life of patients. At present, the effect of antibiotics alone for high perianal abscess is not satisfactory. Loose combined cutting seton (LCCS) can effectively treat high anal fistulas and high perianal abscesses in our clinical practice, but there is no sufficient evidence for its effectiveness in the treatment of high perianal abscesses. The purpose of this study is to observe the effectiveness and safety of LCCS in the treatment of high perianal abscess.Methods: This study is a single-center, prospective, single-blind, randomized, controlled, non-inferiority clinical study. This study will include patients who are diagnosed with high perianal abscesses and hospitalized for surgery in the Department of Proctology in China-Japan Friendship Hospital (enrollment time: from January 2022 through December 2024). Patients in the experimental group will be treated with LCCS, while patients in the control group will be treated with incision and drainage. Follow-ups will be performed at 1, 3, 7, 14, 21, 28, 90, and 180 days after the operation. The main outcome measures are as follows: (I) cure rate; (II) half-year recurrence rate; (III) postoperative pain visual analog scale (VAS) score; (IV) wound healing time; (V) postoperative anal function evaluation by the Wexner scale; (VI) pressure measurement of the anal canal and rectum before and at half a year after surgery; and (VII) the incidence of adverse events.Discussion: This study will assess the effectiveness and safety of LCCS in the treatment of high perianal abscess through a strictly designed randomized controlled study, and provides evidence for treatment in clinical practice, thereby improving the treatment effect and improving patients' quality of life.

Effects of loose combined cutting seton surgery on wound healing and pain in patients with high anal fistula: A meta‐analysis

“… 7 High anal fistulas, extending to the deep external sphincter or beyond, often present complex fistula tracts, making it difficult to accurately identify the fistula's course and its relationship with the sphincter during surgery, resulting in a lower cure rate. 7 , 8 The single cure rate of anal fistula surgery is not the only criterion for evaluating surgical outcomes; effectively reducing postoperative complications, maintaining normal anal sphincter function, alleviating postoperative pain and improving quality of life are current research focuses in colorectal and anal surgery. 9 Fistulectomy, a common surgical technique for high anal fistulas, involves complete exposure and excision of the tract, branches, and abscess cavity, followed by adequate drainage, effectively removing necrotic tissue and eliminating recurrence factors.…”

“…The surgical approach is based on three key principles: identifying the anal canal and its internal opening, excising the tract while preserving the function of the anal sphincter 7 . High anal fistulas, extending to the deep external sphincter or beyond, often present complex fistula tracts, making it difficult to accurately identify the fistula's course and its relationship with the sphincter during surgery, resulting in a lower cure rate 7,8 . The single cure rate of anal fistula surgery is not the only criterion for evaluating surgical outcomes; effectively reducing postoperative complications, maintaining normal anal sphincter function, alleviating postoperative pain and improving quality of life are current research focuses in colorectal and anal surgery 9 .…”

Differences in Gut Microbiota between Healthy Individuals and Patients with Perianal Abscess before and after Surgery

“…Especially the men aged 21-40 years are more likely to develop this disease [ 7 ]. The most common treatment for perianal abscesses is incision and drainage [ 8 , 9 ]. Generally, the patients with perianal abscesses do not need follow-up treatments after surgery, but the pathogenic microorganisms can easily colonize the intestinal tract of patients after surgery [ 10 ].…”