Perianal disease: Updates and controversies in closing the gaps.

Perianal complications are common and morbid in children with Crohn's disease. In this review, we describe the epidemiology, the presentation and diagnosis, evaluation and management. We focus on updates such as the increasing frequency of biologic medications and MRI for evaluation. We also highlight controversies on the timing and approaches to surgical techniques. Finally, perianal disease requires the coordination of multidisciplinary care with nursing, radiology, gastroenterology, and surgery to optimize outcomes - both medical and patient-centered.

Evaluation surgical strategies in perianal fistulas treatment: Efficacy draining seton compared to other surgical approaches; a case-control study.

Background and Aims: Perianal fistula is a prevalent anorectal condition originating from an infectious crypt extending to the external opening. Multiple surgical methods exist for treating perianal fistulas; however, selecting the appropriate options is still controversial. Our study aims to evaluate seton replacement versus other surgical methods in treating perianal fistula. Methods: This study recruited 72 patients presenting with perianal discharge and diagnosed with perianal fistula through intra-sphincteric, trans-sphincteric, and supra-sphincteric examinations at Imam Reza and Besat Hospitals from July 2022 up to March 2023. Regarding case-control design, patients were divided into two groups: the first group (n = 36) underwent seton insertion, while the control group (n = 36) received alternative surgical methods. Follow-up was conducted for 1 month post-discharge, with monthly visits for 6 months. Patients were evaluated for fistula tract healing, seton loosening, and daily secretion rate (based on infected pads) during each visit. Finally, the two groups were compared in terms of improvement rates. Results: In the seton group, approximately 94.4% of patients showed improvement. However, the difference between the groups was insignificant (p = 0.494). Seton replacement was performed in 52% of patients, with the majority requiring replacement twice (61%). Improvement rates were highest among cases with two seton replacements, although the difference was not statistically significant (p = 0.073). Following seton replacement, the most common treatment methods were endoanal flap and fistulotomy, with observed improvement in 10 cases for each procedure. Conclusion: This study highlights that draining seton remains a primary choice for intermediate treatment due to its satisfactory improvement rate and lower requirement for replacement, especially up to two times.

Contemporary management of anorectal fistula.

Anorectal fistula is a common, chronic condition, and is primarily managed surgically. Herein, we provide a contemporary review of the relevant etiology and anatomy anorectal fistula, treatment recommendations that summarize relevant outcomes and alternative considerations, in particular when to refer to a fistula expert.

[On fistulas and threads : Sense and nonsense of seton drainage]. / Von Fisteln und Fäden : Sinn und Unsinn von Seton-Drainagen.

BACKGROUND: In the daily practice of a large proctological center numerous wrong or misplaced fistula threads are encountered. This indicates that there are misconceptions and knowledge gaps in this surgical field in nonspecialized general surgeons. MATERIAL AND METHODS: Comprehensive footage of own experiences in a proctological center shows faulty threads and correct loop placement. RESULTS: In fistula treatment there is still a distinct need for improvement. This synopsis is an educational contribution. CONCLUSION: In the case of a lack of experience in proctological surgery, education and training has to be provided for the decent management of anal fistulas with correct threads.

The management of low trans-sphincteric anal fistula during the COVID-19 pandemic: revisiting the role of the seton.

The management of trans-sphincteric anal fistula (TAF) includes several surgical options; however, during the COVID-19 pandemic, the access to the operating rooms was severely limited, leaving only the choice of minimally invasive procedures. This study aimed to evaluate the safety and effectiveness of the slow cutting seton technique for TAF performed in an outpatient setting during the COVID-19 pandemic.Patients treated for TAF between January 2020 and July 2022 and followed-up for at least 12 months were retrospectively evaluated. A vascular silicone tie used as seton was positioned in the fistula tract using a Lockhart-Mummery fistula probe. The seton was maintained in moderate tension until the sphincter muscle was passed. Percentage and time for healing, recurrence, SF-36, VAS and Vaizey's Score were recorded.Fifty-eight patients [36 male/22 female, median age 56.5 years (IQR 41.25-65.75) [with TAF were included. After a median time of 4 months, complete healing occurred in 53 cases (91.5%), the anal pain VAS decreased from 6 to 0, the anal incontinence scores did not change significantly and the QoL improved significantly in all the SF36 domains. No complications were recorded, but the fistula recurred in five cases (8.5%). Two of them had additional seton treatment, and three underwent other surgical procedures after the COVID-19 emergency.The slow cutting seton technique is a safe and effective treatment for outpatient procedure with minimal patient discomfort. This treatment option in healthcare delivery for TAF should be reconsidered, even outside the limited in-hospital access during the COVID-19 pandemic.

Cutting seton for the treatment of cryptoglandular fistula-in-ano: a systematic review and meta-analysis.

BACKGROUND: The use of cutting seton (CS) for the management of cryptoglandular fistula-in-ano has remained controversial because of reports of fecal incontinence, postoperative pain, and extended healing time. The aim of this review was to provide the first synthesis of studies investigating the use of CS for the treatment of cryptoglandular fistula-in-ano. METHODS: MEDLINE, Embase, and CENTRAL were searched up to October 2022. Randomized controlled trials and observational studies comparing CS with alternative interventions were included, along with single-arm studies evaluating CS alone. The primary outcome was fistula-in-ano recurrence, and secondary outcomes included incontinence, healing time, proportion with complete healing, and postoperative pain. Inverse variance random-effects meta-analyses were used to pool effect estimates. RESULTS: After screening 661 citations, 29 studies were included. Overall, 1513 patients undergoing CS (18.8% female, mean age: 43.1 years) were included. Patients with CS had a 6% (95% CI: 3-12%) risk of recurrence and a 16% (95% CI: 5-38%) risk of incontinence at 6 months. CS patients had an average healing time of 14.6 weeks (95% CI: 10-19 weeks) with 73% (95% CI: 48-89%) of patients achieving complete healing at 6 months postoperatively. There was no difference in recurrence between CS and fistulotomy, advancement flap, two-stage seton fistulotomy, or draining seton. CONCLUSIONS: Overall, this analysis shows that CS has comparable recurrence and incontinence rates to other modalities. However, this may be at the expense of more postoperative pain and extended healing time. Further comparative studies between CS and other modalities are warranted.

Distalization of perianal fistulas after loose silicone seton drainage is a myth.

BACKGROUND: It is often stated that loose seton drainage results in distal migration of a fistula tract in perianal fistula. The aim of the present study was to assess this distalization of trans- and suprasphincteric perianal fistulas after a silicone seton has been inserted. METHODS: Consecutive patients who underwent loose seton placement for the management of a transsphincteric or suprasphincteric fistula between January 2016 and December 2021 with a pre- and postoperative magnetic resonance imaging (MRI) were included in the present retrospective study. The height of the external anal sphincter (EAS) and the level of penetration of perianal fistula through the EAS or puborectal muscle (PRM) were determined on MRI. Primary outcome was migration of the fistula tract through the EAS and PRM. RESULTS: Thirty-eight patients with perianal fistulas were included. Median height of the EAS was 28 (IQR 25-34) mm before seton placement and 27 (IQR 24-33) mm afterward. Median level of perforation was 32 (IQR 17-40) mm before seton placement and 28 (IQR 17-40) mm afterward (p = 0.37). One fistula (3%) was downgraded from mid to low transsphincteric and was laid open after 14.9 months of loose seton drainage. CONCLUSIONS: No statistically significant distalization of complex fistula tracts after loose silicone seton drainage was found. Some complex fistulas may downgrade to a less complex fistula after long-term seton drainage. However, loose silicone seton drainage should not be offered to patients as a treatment option to downgrade a complex fistula to a simple one or even have the hope to heal it.

Evaluation of the Cutting Seton Technique in Treating High Anal Fistula.

Objectives Fistula-in-ano is a common condition that negatively affects the quality of life of its sufferers. A high anal fistula poses a significant challenge for surgeons due to its proximity to the anorectal ring and the potential risk of incontinence rather than recurrence. Many modalities have been used in a justified search for a satisfactory cure for the condition, but the seton remains a mainstay of surgical treatment. Therefore, the rationale of this study is to assess the outcome of treating a high anal fistula using the cutting seton technique in a hospital in Al Madinah, Saudi Arabia. The evaluation is intended through a retrospective analysis of patients' outcomes, comparing its effectiveness to similar articles. Methods This is a retrospective study that includes 50 patients with high anal fistulas who were treated with a cutting seton at the National Guard Hospital over a four-year period (2019-2022). Information obtained from medical records included clinical and demographic data. The data collected during the study was compiled and statistically analyzed using the SPSS Statistics version 26.0 (IBM Corp. Released 2019. IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp.). A p-value of <0.05 was considered statistically significant. Results A total of 50 patients with high anal fistula treated with a cutting seton were included: 82% were males and 18% were females, with 66% below 45 years of age. Approximately 92% had inter-sphincteric fistulas, and only 28% had a recurrent fistula. Almost all patients (98%) had an MRI done before surgery. Around 70% of patients were completely cured, 26% had minor complications, 8% of the operated patients experienced mild incontinence, and only one recurrence (2%). Conclusion The cutting seton is still a valid modality in treating patients with a high anal fistula, as it is considerably safe, effective, and yields good outcomes. Standard preoperative assessment and thorough surgical techniques are cornerstones for achieving a satisfactory outcome.

Slowly cutting, loose seton ligature and staged fistulotomy for healing of idiopathic perianal fistula and influence on anal continence.

PURPOSE: To investigate the ability of a "slowly cutting, loose seton ligature and staged fistulotomy" to heal perianal fistulas, the time needed with the seton ligature, recurrence rate, influence on anal continence, health-related quality of life (HRQoL), and patient satisfaction. METHODS: Observational single-center study. We reviewed the medical records of all patients with primary surgeries from January 1, 2009, to December 31, 2018. The patients answered a questionnaire pre- and postoperative on anal continence (St. Mark's incontinence score) and HRQoL (The Short Health Scale). Satisfaction with the operation was answered postoperatively. RESULTS: Forty-three patients (37 men, 6 women) were included. Initially 41 of 43 healed (95%). Three patients (7%) had a recurrence, two healed after retreatment. The median follow-up was 55 months (IQR, 4). Thirty-four patients (79%) responded to the questionnaire. At follow-up, forty (93%) patients were healed. The median time treated with a seton ligature in the healed patients was 13 months (IQR, 14). St. Mark's incontinence score preoperative was median 2 (IQR, 9) and after the operation median 1 (IQR, 4). The Short Health Scale improved from median 20 (IQR, 5) preoperatively to 5 (IQR, 5) postoperatively, p < 0.001. Patient satisfaction was median 1 (= very satisfied) (IQR, 1). CONCLUSION: A "slowly cutting, loose seton ligature followed by a staged fistulotomy", heals the vast majority of perianal fistulas with minor or none influence on continence and few recurrences. Patient-reported HRQoL improves greatly, and patient satisfaction is high.

Clinical and magnetic resonance imaging spectrum of complex perianal fistulizing Crohn's disease: A cohort study from northern India.

BACKGROUND: Fistulizing perianal Crohn's disease (CD) is a debilitating condition associated with significant morbidity and reduction in the quality of life. Magnetic resonance imaging (MRI) of the pelvis is the preferred imaging modality for the comprehensive assessment of the perianal fistula. There is a paucity of data from India on the MRI spectrum of complex perianal fistula in CD. METHODS: A single-centre cross-sectional analysis of patients with fistulizing perianal CD, who underwent pelvic MRI between January 2020 and December 2021, was performed. The clinical (age, sex, disease duration, disease location and behavior, disease activity [Perianal Disease Activity Index, PDAI] and treatment received) and radiological (number and location of fistulae, extensions, number and location of internal and external openings, fistula activity, presence or absence of perianal abscess and associated proctitis) characteristics of complex perianal fistula (defined according to the American Gastroenterological Association classification) were recorded. RESULTS: Of total 175 patients with CD who attended the gastroenterology clinic during the study period, 27 (15.42%) (mean age 42±15.5 years, 62.96% females and median disease duration four years) had complex perianal fistula and were included in the analysis. The mean PDAI was 5.48±2.53. The median Van Assche Index was 17 (interquartile range [IQR] 13-19). A majority (96.29%) of the fistulae were trans-sphincteric and four (14.81%) fistulae extended into the supralevator space. All fistulae were active on MRI. Concomitant perianal abscess and proctitis were seen in 59.26% (n=16) and 62.96% (n=17) of patients, respectively. Combination therapy with biologics and antibiotics/immune-suppressants were the most commonly prescribed medical therapy. Six (22.22%) patients underwent combined medical and surgical (non-cutting seton, fistulectomy, fecal diversion) treatment. CONCLUSION: The cumulative risk of the development of fistulizing perianal CD in a northern Indian cohort was similar to the western populations. Complex perianal fistulae were predominantly trans-sphincteric and commoner in females. MRI evaluation is pivotal for the delineation of fistula anatomy, assessment of disease extent and activity and the evaluation of concomitant perianal abscess and other complications.

A pilot study on staged surgery by delta video-assisted anal fistula treatment (dVAAFT) for complex anal fistula.

Complex anal fistulas (CAF) present a challenge in achieving healing while preserving anal sphincter function. This study aims to introduce a novel staged approach for CAF treatment, combining video-assisted anal fistula treatment (VAAFT), seton placement, and other staged approaches. Consecutive patients with CAF underwent the staged approach involving VAAFT and seton placement. Data on patient demographics, fistula characteristics, and operative findings were collected. Pre-operative work-up included clinical evaluation, endoanal ultrasonography (EAUS), and magnetic resonance imaging (MRI). Surgical techniques and outcomes were evaluated. Eighteen patients (median age 38 years) were included. Misplacement of a previously placed seton was observed in 64% of cases. VAAFT combined with seton placement achieved simplification and healing of secondary tracts in 66% of cases. Operative times significantly decreased across interventions. At a median follow-up of 14 months, complete healing was achieved in 2 patients, with 1 patient demonstrating persistence of the fistula. Post-operative complications were observed in 11% of patients, with no deterioration in continence. The staged approach combining VAAFT, seton placement, and staged procedures offers a potential solution for treating CAF. VAAFT provides diagnostic and therapeutic benefits, simplifying the fistula anatomy and optimizing seton placement. The approach allows subsequent procedures based on individual fistula characteristics.

Analysis of Ambulatory Proctologic Surgery for Simple Anal Fistulas in Terms of Recovery, Complications, Recurrence, and Cost.

Background Ambulatory anorectal surgeries have increased in the last few years. This clinical study aimed to compare general operating room conditions with outpatient procedures for simple anal fistulas in terms of healing success, recurrence, cost, complications, and sustainability. Methodology Only primary fistulotomy and seton application for simple anal fistulas were retrospectively analyzed. Results Two-hundred fifty patients (73.7%) were male, and 89 (26.3%) were female. Sixty patients (17.7%) were treated in the operating room, and 279 (82.3%) were treated in the outpatient clinic conditions. Of the ambulatory surgeries, 160 patients underwent fistulotomy and 119 patients loose seton. On the other hand, 34 patients underwent fistulotomy and 26 patients loose seton in operating room conditions. No significant difference was found between the groups according to the distribution of age, gender, complications, and recurrence (P > 0.05). Cost-effectiveness assessment according to the place (ambulatory/operating room) and type of operation (fistulotomy/loose seton) reveals that ambulatory surgery provides significantly more savings (P < 0.001). Conclusions For simple anal fistulas, ambulatory anorectal surgery is a safe approach that can be performed at a lower cost than operating room conditions.

Treatment of pediatric fistula-in-ano-Sphincter-sparing non-cutting seton placement as the future treatment of choice?

Background: Therapeutic principles of fistula-in-ano (FIA) are lacking evidence-based consensus on treatment options. Non-cutting, sphincter-sparing options have not been published for infancy and childhood FIA. Patients and methods: We are presenting retrospective data on FIA treatment with non-cutting seton placement between 2011 and 2020. Data were collected based on medical records and complemented by patients' contact for follow-up analyses between November 2021 and October 2022. Data were analyzed regarding the outcome variables of recurrent FIA and recurrent perianal abscess. Furthermore, outcomes in different age groups were compared (<1/1.5-12 years of age). Results: Treatment duration with non-cutting seton was at a median of 4.6 months and was not associated with recurrent FIA (p = 0.8893). Overall recurrence rate of FIA within an observation time of 9 months postsurgically was at 7% (n = 3/42) and was only seen in infancy, whereas recurrent perianal abscess was mainly observable in children (n = 2, p = 0.2132). Comparison of age groups revealed no significant differences. Of the 42 included patients, 37 responded in the follow-up analysis, resulting in a response rate of 88% with a median follow-up time of 4.9 years. Fecal incontinence was postsurgically only seen in two patients, who were diagnosed prior to surgery and symptoms remained unchanged. Conclusions: Non-cutting seton placement might be a promising option in the treatment of FIA in infancy and childhood. Perioperative settings like duration of placed seton and antibiotic treatment have to be discussed in further prospective, enlarged population-based studies.

The use of a loose seton as a definitive surgical treatment for anorectal abscesses and complex anal fistulas.

BACKGROUND: There is no consensus regarding the standard treatment method for anorectal abscesses accompanied by anal fistulas and complex anal fistulas. Simultaneous surgical treatment of the underlying anal fistula with anorectal abscess drainage is controversial due to incontinence problems. OBJECTIVES: We aimed to investigate the effectiveness of the loose seton method for the treatment of chronic anal fistulas and acute anorectal abscesses accompanied by anal fistula. MATERIAL AND METHODS: In this retrospective study, 114 patients who were operated on in our clinic due to chronic anal fistulas and anorectal abscesses with an applied loose seton between 2020 and 2022 were included in the study. The patients were divided into 2 groups: those with chronic complex anal fistula and those with anorectal abscess accompanied by anal fistula. The groups were compared in terms of their continence status, rate of recurrence, recurrent abscess formation, postoperative pain scores, duration of operation, and demographic characteristics. RESULTS: Of the patients included in the study, 78 had a complex chronic anal fistula, and 36 had an anorectal abscess accompanied by an anal fistula. There were no differences between the demographic characteristics of the 2 groups. The mean seton dissociation time was 6.8 (3-19) months. Gas or stool leakage was not observed in patients during the mean follow-up period of 18 (6-30) months. There was no difference in postoperative continence levels between the 2 groups. No recurrent fistulas were observed in patients during the follow-up period. Recurrent abscesses were observed in 5 (13.9%) patients in the anorectal abscess group. Abscesses due to insufficient drainage were observed in 2 (2.6%) patients in the chronic fistula group. There was no significant difference in operation time between the 2 groups. CONCLUSION: A loose seton can be a safe and effective method for the treatment of abscesses. It is a painless surgical method that produces good results in the treatment of all types of abscesses.

A Comparison of Different Surgical Treatments for Complex Anal Fistula: A Systematic Review.

Fistula-in-ano is a common proctological condition that primarily affects younger people and leads to chronic morbidity. An anal fistula is divided into simple and complex fistulas. A complex fistula is a challenging problem due to higher recurrence rates and incontinence associated with surgery. Many new methods have been developed for the closure of complex fistula-in-ano, but there is no single best method. The aim of this study is to identify a superior surgical technique for treating complex/high cryptoglandular perianal fistulas (HCPFs). A literature search was done using PubMed and Google Scholar for the period of 2012-2021. Articles that contain surgical treatment for complex anal fistula in the English language published in the last 10 years were included. The types of studies included were randomized controlled trials (RCTs), meta-analyses, systematic reviews, cohort studies, and traditional reviews. Articles excluded were those done more than 10 years ago, in other languages, and containing simple fistula management only. Nine studies were included in the review; a systematic review and meta-analysis concluded that no single method is effective. The ligation of the intersphincteric fistula tract (LIFT) procedure seems to be a promising and effective technique as it has a low rate of fecal incontinence as compared to other methods. Biological techniques give variable success rates so does fistula plug (FP). Mucosal advancement flap (MAF) and rerouting seton give good results according to one study. Fistula plug gives variable results and is not a preferred method. Ligation of the intersphincteric fistula tract (LIFT) seems to be a promising new technique for complex anal fistulas, but the data available is not enough to determine the best method. More randomized trials are required to compare traditional techniques and emerging new biological methods to see the best technique available.

A Retrospective Critique of the Various Sphincter-preserving Surgical Procedures for Ischiorectal Fistula.

In the 1950s, the cause of anal fistulas was identified as an infection of the anal gland (cryptoglandular infection theory). Thereafter, treatment for this disorder began in the 1960s with the lay-open procedure, which involved incising the sphincter and the fistula tract. However, it was found that too much invasion into the sphincter could result in postoperative fecal incontinence. Thus, to reduce such risk, sphincter-preserving surgery was applied for superficial anal fistula in 1961 and for deep anal fistula (ischiorectal fistula) in 1965. Over the years, more effective sphincter-preserving procedures for ischiorectal fistula have been developed to improve the quality of life of the patient. In this review article, we aim to first introduce the basic surgical techniques for ischiorectal fistula. We will discuss the anatomy of the anus and the pathogenesis of ischiorectal fistula and will provide some diagnostic methods. Representative sphincter-preserving procedures that have been performed for ischiorectal fistula since 1965 will also be categorized and outlined chronologically. The discussion will look at the following techniques for ischiorectal fistula and outline the advantages and disadvantages of each procedure so that they can be used as a reference for ischiorectal fistula surgery in the future: the lay-open procedure (fistulotomy and fistulectomy), the Hanley procedure (first partial sphincter-preserving procedure), the muscle-filling procedure, the Moriya method and Ui method (modified partial sphincter-preserving procedure), the Takano method and the sphincter-preserving lateral procedure (complete sphincter-preserving procedure), the seton method (a cross between the lay-open procedure and sphincter-preserving procedure), and the overseas sphincter-preserving procedure.

Outcomes in High Perianal Fistula Repair Using Video-Assisted Anal Fistula Treatment Compared With Seton Use: A Randomized Controlled Trial.

Background Anal fistula, or fistula-in-ano, is a chronic abnormal communication between the epithelialized surface of the anal canal and the perianal skin. Video-assisted anal fistula treatment (VAAFT) is a novel, minimally invasive, and sphincter-saving alternative to traditional seton use. This study aimed to determine the short-term and long-term outcomes of VAAFT compared with seton treatment. Material and methods This randomized control trial was conducted at the Department of Surgery, Services Hospital, Lahore, from August 2014 to July 2020. Patients were randomly assigned to either the VAAFT group or the seton group, and postoperative outcomes were assessed for up to three years. Results The study included 80 patients (64 men and 16 women) with a mean age of 39.1 ± 11.2 years. The most common type of fistula was a transsphincteric fistula (n=36, 45%). The mean duration of surgery was significantly longer in the VAAFT group (78.6 minutes) compared with the seton group (36.97 minutes; p=0.000). The mean pain score was significantly higher in the VAAFT group (4.22) compared to the seton group (2.82, p=0.000). The mean time to return to work was shorter in the VAAFT group (7.4 days) than in the seton group (9.2 days, p=0.000). The mean healing time was significantly shorter for patients treated with VAAFT (5.75 weeks) than for those treated with a seton (9.7 weeks; p=0.000). Fistula recurrence after one, two, or three years was not significantly different between groups, and neither group had incidences of anal incontinence. Conclusions VAAFT is associated with earlier healing time and earlier return to work than the traditional seton technique, with no significant difference in fistula recurrence. VAAFT is minimally invasive and, when used in patients where indicated, allows for a prompter return to routine life for the patients, which is an optimal outcome for both patients and physicians.

The Value of Cutting Seton for High Transsphincteric Anal Fistula in the Era of Its Misery.

Objectives: We studied the outcome of cutting seton in the treatment of a high transsphincteric anal fistula in Sudan. Methods: This was a prospective study of high transsphincteric anal fistulas at Kassala Police Hospital, Sudan, over the course of 24 months (2016-2017). The main outcomes measured were recurrence, incontinence and primary healing rates. Results: The cases of 72 patients treated with cutting seton for high transsphincteric fistula were analysed, with 50 (70%) of the patients being male and 22 (30%) being female. Forty-eight (66.7%) patients required two sessions of seton tightening with a duration of seton treatment of 30 days and 24 (33.3%) patients required three sessions with a duration of seton treatment of 45 days. Only one patient (1.4%) had flatus incontinence. Three (4.2%) patients had minimal bleeding from the seton site and two (2.8%) patients experienced fistula recurrence. Twenty-six (36%) patients achieved complete healing within 30 days, while 36 (54.3%) patients healed within 60 days. The remaining seven (9.7%) patients healed after 60 days. Chronic pain was reported by two (2.8%) patients after complete healing. Conclusion: In Sudan, cutting seton remains relevant, as it produces minimal incontinence with a low recurrence rate in high transsphincteric fistula treatment.

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

Background: High perianal abscess is an emergency in the anorectal department. It can result in long-term 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. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100049198.