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Objectives: To identify early treatment outcomes among patients having undergone ligation of intersphincteric fistula tract for complex fistula-in-ano in a tertiary care setting. METHODS: The single-centre retrospective study was conducted at the Aga Khan University Hospital, Karachi, and comprised data from January 2016 to January 2021 of adult complex fistula-in-ano patients who underwent ligation of intersphincteric fistula tract procedure. All surgeries were done by a single surgeon. Pre- and post-operative Wexner continence scores were measured, and various factors, including change in continence, complete wound healing, postoperative infection and recurrence, were assessed. Data was analysed using SPSS 23. RESULTS: Of the 20 patients, 15(75%) were females and 5(25.0%) were males. The overall mean age was 38.4±13.8 years. The median duration of surgery was 65 minutes (interquartile range: 57-99 minutes). There were 2(10%) patients who showed a change in continence after surgery to flatus alone. Complete healing was noted in 11(55%) patients. Recurrence was noted in 8(40%) patients; trans-sphincteric fistula-in-ano in 2(10%) patients, and inter-sphincteric fistula in 6(30%). Body mass index had a significant association with the change in continence (p=0.028). CONCLUSIONS: There was a comparable risk of recurrence after ligation of intersphincteric fistula tract surgery, but among those without recurrence, the post-operative outcomes were optimal and no faecal incontinence was noted.

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OBJECTIVE: To compare the efficacy and postoperative complications of laser and hybrid seton methods in the treatment of perianal fistula (PF). STUDY DESIGN: A descriptive cross-sectional study. Place and Duration of the Study: Department of General Surgery, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Turkiye, from January 2021 to April 2022. METHODOLOGY: A total of 76 patients, with 46 in the hybrid seton group and 30 in the laser group, were included in the study. Perianal fistula classification was based on preoperative magnetic resonance imaging. The Likert satisfaction scale was assessed for patient satisfaction and the Cleveland Clinic Florida Faecal Incontinence (CCF-FI) scoring system was used for incontinence. Treatment outcome was determined based on success rate and postoperative faecal incontinence. RESULTS: The mean age of the patients was 43 ± 13 years and 59 (78%) of them were male. Forty-seven (62%) patients had simple fistula. Acute and late complications were significantly higher in the hybrid seton group than in the laser group (p <0.001). According to the Likert satisfaction scale, the rate of unsatisfied patients was significantly higher in the laser group than in the hybrid seton group (p = 0.02). According to the CCF-FI scoring system, incontinence was significantly higher in the hybrid seton group than in the laser group (p = 0.01). Treatment failure was higher in the laser group (p = 0.03). CONCLUSION: The laser method has lower intraoperative / postoperative complications, but higher treatment failure and lower patient satisfaction compared to the hybrid seton method. KEY WORDS: Anal fistula, Fecal incontinence, Laser therapy, Outcome, Loose seton method.

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BACKGROUND: The efficacy of injections of mesenchymal stem cells (MSC) for anal fistula treatment may be impaired by the persistence of stools passing into the fistula, causing bacterial contamination and a local inflammatory reaction. We aimed to compare remission rates between patients treated by MSC injection with simple sutures and those treated with a rectal advancement flap. METHODS: This single-center prospective study compared the first patients who underwent internal opening closure with sutures with the subsequent patients treated with a flap. Complete clinical remission was defined as complete closure of the external opening(s) without pain or discharge, and complete radiological remission was defined as a Magnifi-CD score of 0. RESULTS: We compared the first 42 patients who had sutures with the 20 subsequent patients who had an advancement flap. The median follow-up was 15.5 [8.8-24.9] months. The cumulative incidence of complete clinical response at M12 was 53.8% [38.1-69.6%] in the suture group versus 93.3% [77.4-100.0] in the flap group (p < 0.001). The Magnifi-CD score was 0 for 41.7% [25.5-59.2%]) of patients treated with sutures versus 72.7% [39.0-63.9%]) of patients treated with a flap (p = 0.093). Anal incontinence score did not differ between the two groups. Practicing an advancement flap was the only significant factor associated with complete clinical remission over time (adjusted HR [95% CI] of 2.6 [1.4-4.9], p = 0.003). CONCLUSIONS: Complete clinical remission rates following MSC injection are significantly higher after closure of the internal opening with a rectal flap than after closure with sutures, without consequences on anal continence.

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PURPOSE: Surgical procedures for anorectoplasty for anorectal malformations (ARMs), particularly rectourethral fistula (RUF), depend on the institution. We investigated the diagnosis and treatment of RUF in male patients with ARMs in Japan using a questionnaire survey. METHODS: An online survey inquiring about the diagnosis and treatment (diagnostic modalities, surgical approaches, fistula dissection devices, and fistula closure techniques) of each type of ARM in male patients was conducted among institutional members of the Japanese Study Group of Anorectal Anomalies. Fisher's exact test was used to compare surgical methods between posterior sagittal anorectoplasty (PSARP) and laparoscopy-assisted anorectoplasty (LAARP). RESULTS: Sixty-one institutions (100%) completed the survey. LAARP was the preferred approach for high-type ARM (75.4%). PSARP was preferred for intermediate-type ARM (59.0%). Monopolar devices were most commonly used (72.1%) for RUF dissection. Blunt dissection was more frequent in the PSARP group (PSARP vs. LAARP: 55.6 vs. 20.0%, p < 0.005). Cystoscopy/urethroscopy to confirm the extent of dissection was used more frequently in the LAARP group (70.0% vs. 25.0%, p < 0.005). Clips and staplers were used more frequently in the LAARP group (p < 0.05). CONCLUSION: Distinct fistula management strategies for PSARP and LAARP were revealed. Further studies are needed to investigate the postoperative outcomes associated with these practices.

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BACKGROUND: There are limited tools to measure the burden of disease and effectiveness of medical/surgical interventions in patients with cryptoglandular fistulas. The aim of this study was to explore concepts that are relevant and important to patients with complex cryptoglandular fistulas (CCF) and to develop a patient-centred, disease-specific, patient-reported outcome measure (PROM) to assess symptom burden and impacts of CCF. METHODS: A targeted literature review was conducted, followed by one-to-one telephone interviews with five colorectal surgeons (USA, n = 3; UK, n = 1; Spain, n = 1) and 20 US adult patients with CCF to inform the development of a conceptual model and a CCF-specific PROM. The targeted literature review informed the development of the preliminary conceptual model and identified a PROM in the literature that was used as a reference to generate the draft CCF-specific PROM. The colorectal surgeon interviews provided insights on the experience of patients with CCF to refine the conceptual model, formulate probing questions for use in patient interviews, and to develop the draft CCF-specific PROM. Patients' descriptions of their experiences with symptoms and the impacts on their lives and evaluation of the draft CCF-specific PROM in concept elicitation and cognitive interviews were used to develop the final conceptual model and final CCF-specific PROM. RESULTS: Ten symptoms (odour, pain during bowel movement, abscess, post-operative pain, discharge/drainage/leakage, anal/perianal pain, inflammation/swelling, skin irritation, bleeding and itchiness) and 11 impacts (discomfort, inability to exercise, embarrassment, difficulty sitting, worry about disease, adapted life to maintain hygiene, negatively impacted social life/isolation, inability to perform daily activities, reduced interest in sex, negatively impacted intimate relationships and negatively impacted mood) were reported as most salient by patients. The patient experience, clinician perspective, and literature review provided input to item generation. Evaluation of relevance and patient understanding through cognitive interviews with patients provided evidence for the content validity of the new patient-reported outcome measure: the 20-item Complex Cryptoglandular Fistula Questionnaire™ (CCFQ-20™). CONCLUSION: The CCFQ-20™ is a new clinician-guided, patient-validated, disease-specific patient-reported outcome measure that measures disease impact and quality of life in patients with CCF.

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INTRODUCTION: Fistula is a common complication of Crohn's disease (CD). Treatment with biologics has been associated with fistula healing. Long-term persistence is an important factor for a chronic inflammatory process such as fistula. This study described 24-month persistence and time-to-surgery endpoints among bio-naïve patients with CD and intestinal fistula who were initiated on ustekinumab. METHODS: Adults with CD and any enteric or perianal fistula initiated on ustekinumab (index date) between September 23, 2016, and March 2, 2022, were selected from the IQVIA PharMetrics® Plus database and followed up to 24 months. Persistence on ustekinumab (no gaps in days of supply of > 120 days) and composite endpoints of being persistent while on monotherapy and persistent while corticosteroid free were also assessed. The date of surgery was defined as the date of first claim for any CD-related surgeries. Persistence and time-to-surgery endpoints were assessed from the index date until the earliest of discontinuation (event), immunomodulator or other biologic use (event), corticosteroid use (event), date of surgery (event), 24-month follow-up or data end (censoring) using Kaplan-Meier analyses. RESULTS: The sample included 445 patients (mean age: 42.8 years; 56.6% female). The most common type of fistula was anal fistula (36.0%). At 24 months after ustekinumab initiation, 64.2% of patients remained persistent (95% confidence interval [CI] 55.8-71.4). Furthermore, 53.3% of patients were persistent while on monotherapy (95% CI 45.1-60.7), and 45.6% of patients were persistent while being corticosteroid free (95% CI 36.9-53.8). At 24 months, 22.8% (95% CI 17.0-30.3) of patients underwent any CD-related surgery. CONCLUSION: This study quantified long-term persistence on ustekinumab among bio-naïve patients with CD and fistula. Over half of patients initiated on ustekinumab were persistent and persistent while on monotherapy 24 months after initiation. Time-to-surgery estimate was comparable to existing evidence. These findings support ustekinumab as a treatment option for long-term management of CD with fistula.

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AIM: Complex anal fistula poses a significant challenge for anorectal surgeons due to its high risks of recurrence and incontinence. A sphincter-preserving procedure named endorectal advancement flap (ERAF) is gradually being applied to clinical practice. Therefore, this meta-analysis aims to evaluate the efficacy and safety of ERAF in managing anal fistula. METHODS: We searched PubMed, Embase, Cochrane, and Web of Science databases for relevant manuscripts published from 29 August 2003 to 29 August 2023. Among these studies, outcomes included healing rate, recurrence rate, incontinence rate, and complications. Furthermore, the quality of the included studies was assessed using the Newcastle-Ottawa Scale (NOS) and the Cochrane risk-of-bias tool. The heterogeneity was determined using the chi-squared test and I2 statistic. A random effects model was applied if significant heterogeneity (p < 0.05 and I2 > 50%) was observed. Sensitivity analysis was conducted by excluding studies with a high risk of bias. RESULTS: Thirty-eight studies were included in the present analysis, involving 1559 participants. The pooled healing rate and recurrence rate of ERAF were 65.5% (95% confidence intervals (CI): 57.6%-73.4%) and 19.6% (95% CI: 14.8%-24.4%), respectively. The pooled incontinence rate was 10.6% (95% CI: 6.0%-15.1%). According to the subgroup analysis, the healing rate, recurrence rate, and incontinence rate of ERAF for fistula associated with inflammatory bowel disease (IBD) were 53.9% (95% CI: 38.1%-69.7%), 32.6% (95% CI: 21.3%-43.8%), and 2.8% (95% CI: 0%-10.6%), respectively. For patients without IBD, the healing rate, recurrence rate, and incontinence rate of ERAF were 70.6% (95% CI: 63.9%-77.4%), 15.7% (95% CI: 9.9%-21.5%), and 16.5% (95% CI: 8.1%-24.9%), respectively. We observed that bleeding, local infection or abscess, flap dehiscence, and haematomas were the common complications, with incidences of 2.2% (95% CI: 0%-4.5%), 9.5% (95% CI: 4.7%-14.4%), 10.4% (95% CI: 0.0%-21.6%), and 12.4% (95% CI: 0%-27.6%), respectively. CONCLUSIONS: ERAF may be an optional treatment for anal fistula from the perspective of effectiveness and safety. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42023451451.

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The association between anal fistula patients and colorectal cancer, as well as the potential pathophysiological mechanisms, remains unclear. To explore the relationship between anal fistula and colorectal cancer and its potential mechanisms. Analysis of GEO and TCGA databases. Disease-related genes were also referenced from Coremine Medical, GeneCard and OMIM. Core hub genes were identified through protein-protein interaction analysis by intersecting differentially expressed genes from the datasets with disease data. On one hand, a prognostic model was developed using genes and its prognostic role was validated. On the other hand, the optimal diagnostic genes were selected through machine learning. Mendelian randomization (MR) analysis was conducted to explore the potential causal link between anal fistula and colorectal cancer. Thirteen core genes were identified (TMEM121B, PDGFRA, MID2, WNT10B, HOXD13, BARX1, SIX2, MMP1, SNAL1, CDKN2A, ITGB3, TIMP1, CALB2). Functional enrichment analysis revealed that the intersecting genes between anal fistula and colorectal cancer were associated with extracellular matrix components, signalling pathways, cell growth, protein modification, as well as important roles in cellular activities, tissue and organ development, and biological function maintenance. These genes were also involved in pathways related to Wnt signalling and colorectal cancer development. Prognostic analysis and immune infiltration analysis indicated a close relationship between core hub genes and the prognosis and immune infiltration in colorectal cancer. Machine learning showed that core genes played an essential role in the diagnostic differentiation of colorectal cancer. MR results suggested no causal relationship between anal fistula and colorectal cancer. This study identified shared core genes between anal fistula and colorectal cancer, involved in various pathways related to tumour development. These genes play crucial roles in prognosis and diagnosis.

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INTRODUCTION: This study aimed to determine the efficacy and safety of autologous PRP in anal fistula. METHODS: The search was done in electronic databases such as; PubMed, Scopus, Google Scholar, Embase, and Cochrane Library. The outcomes investigated in this study were the rate of improvement, the rate of recurrence, and the rate of fecal incontinence. RESULTS: Cure, incontinence, and recurrence rates were 68% (95% CI, .60-.76), 27% (95% CI, .12-.46), and 18% (95% CI, .12-.26), respectively. The pooled improvement ratio in patients treated with PRP compared to control group was 1.35 times, which was statistically significant (pooled OR=1.35, 95% CI, 1.14-1.60, P<001). The pooled recurrence ratio in patients treated with PRP compared to control group was 1.17, which was not statistically significant (pooled OR=1.17, 95% CI, 0.44-3.11). DISCUSSION: Platelet-rich plasma is an effective method of healing people with anal fistula.

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BACKGROUND/AIMS:  The purpose of this study was to investigate whether computed tomography enterography can be used to predict the presence of perianal fistula in Crohn's disease patients. MATERIALS AND METHODS:  According to the presentation of perianal fistula or not, this study divided retrospectively included Crohn's disease patients into 2 groups. The disease duration, incidence of involved intestinal segments, and scoring of the activity of the lesions in all patients were statistically analyzed to explore significant factors between the 2 groups. The statistically significant findings identified in the univariate analysis were incorporated into the multivariate analysis. Logistic regression models were subsequently constructed to assess the predictive factors associated with the occurrence of perianal fistula in individuals with Crohn's disease.The contribution of each factor to the outcome variable was confirmed by the nomogram. The clinical utility of the nomogram was confirmed by calibration and decision curves. RESULTS:  There were 40 cases with perianal Crohn's disease and 58 without perianal Crohn's disease. After univariate and multivariate analysis, disease duration (early stage of Crohn's disease), ascending colon, and rectum were identified as the independent predictive factors for perianal fistula in Crohn's disease patients. The clinical utility of the nomogram was effective, which implied potential benefits for Crohn's disease patients. CONCLUSION:  Computed tomography enterography can be used to predict the presence of perianal fistula in Crohn's disease patients by analyzing the location and the stage of the disease.

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The perianal disease affects up to one-third of individuals with Crohn's disease (CD), causing disabling symptoms and significant impairment in quality of life, particularly for those with perianal fistulising CD (PFCD). The collaborative effort between gastroenterologists and surgeons is essential for addressing PFCD to achieve fistula closure and promote luminal healing. Limited fistula healing rates with conventional therapies have prompted the emergence of new biological agents, endoscopic procedures and surgical techniques that show promising results. Among these, mesenchymal stem cells injection is a particularly hopeful therapy. In addition to the burden of fistulas, individuals with perianal CD may face an increased risk of developing anal cancer. This underscores the importance of surveillance programmes and timely interventions to prevent late diagnoses and poor outcomes. Currently, there is no established formal anal screening programme. In this review, we provide an overview of the current state of the art in managing PFCD, including novel medical, endoscopic and surgical approaches. The discussion also focuses on the relevance of establishing an anal cancer screening programme in CD, intending to propose a risk-based surveillance algorithm. The validation of this surveillance programme would be a significant step forward in improving patient care and outcomes.

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BACKGROUND: Sphincter-preserving techniques like autologous compound platelet-rich fibrin foam have gained popularity, offering potential for better functional outcomes in anal fistula treatment. The present study aimed to evaluate the efficacy and safety of Obsidian RFT®. METHODS: The study conducted a retrospective analysis from January 2018 to December 2022 on patients who received anal fistula closure with Obsidian RTF® at the Department of General Surgery, Medical University of Vienna. Clinical diagnosis, complemented by radiographic imaging, was employed to confirm inconclusive cases. Demographic and fistula characteristics and postoperative data were collected from electronic records following STROCSS criteria. RESULTS: Fifteen patients received Obsidian RFT® treatment for anal fistulas. We found no intra- and postoperative complications. The median hospital stay was 3 days. After a median follow-up of 32 months, a closure rate of 53.3% was detected. Non-significant differences were observed in various variables, yet trends emerged, indicating associations between abscess presence and non-healing fistulas. A distinct age threshold (≥ 42.7 years) served as an indicator for an inability to achieve anal fistula cure. CONCLUSION: Obsidian RFT® represents a safe, minimally invasive operative procedure. Approximately half the patients experienced healing, with better outcome in a younger population. TRIAL REGISTRATION: Ethical Approval number Medical University of Vienna (#1258/2018). This study was registered retrospectively in ClinicalTrials.gov (NCT06136325).

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It is generally recommended to refrain from taking rectal biopsies in radioproctopathy. Herein we describe the clinical characteristics of urorectal fistulas after such biopsies in five patients. Conservative treatment is rarely successful. Diagnostic difficulties and comorbidities limiting the possibilities for radical surgical treatment options (i e pelvic exenteration) for urorectal fistulas are discussed.

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BACKGROUND: Few studies report outcomes for enhanced recovery pathways in ambulatory anorectal surgery. We hypothesize that an ambulatory anorectal enhanced recovery pathway with multimodal analgesia can reduce postoperative opioid use. OBJECTIVE: To compare postoperative opioid use in patients undergoing ambulatory anorectal surgery who receive multimodal analgesia versus standard of care without multimodal analgesia. DESIGN: A prospective randomized trial of patients undergoing elective anal fistula or hemorrhoid surgery from September 2018 to May 2022. SETTING: Urban teaching hospital. PATIENTS: Adults aged 18 to 70 years undergoing elective anal fistula or hemorrhoid surgery from September 2018 to May 2022. INTERVENTION: Multimodal enhanced recovery pathway including preoperative and postoperative nonopioid analgesia with oral acetaminophen, gabapentin, and ketolorac. MAIN OUTCOME MEASURES: Primary end point was oral opioid use during the first postoperative week. Secondary end points included maximum pain and nausea scores, adverse events, and emergency room or hospital admissions during the first 30 days postoperatively. RESULTS: Of the 109 enrolled patients, 20 were lost to follow-up. The remaining 89 patients had a median age of 38 years (range, 20-67) and included 41 women (46%). There were no significant differences between the enhanced recovery protocol arm and non-enhanced recovery protocol arm in terms of preoperative and surgical characteristics. The primary end point of this study, that is, oral morphine milligram equivalents use during the first week, was significantly higher among patients in the non-enhanced recovery protocol arm (79 mg; range, 0-600) than patients in the enhanced recovery protocol arm (8 mg; range, 0-390; p = 0.002). On subgroup analysis, both fistula and hemorrhoid surgery patients assigned to the non-enhanced recovery protocol arm took significantly higher oral morphine milligram equivalents in the first week than patients in the enhanced recovery protocol arm. There was no significant difference in secondary end points. LIMITATIONS: Patients and providers were not blinded. Our findings are limited to hemorrhoid and fistula surgery and may not be applicable to other anorectal procedures. CONCLUSIONS: Enhanced recovery protocols including multimodal analgesia should be used in elective anal fistula and hemorrhoid surgery to decrease postoperative opioid use. See the Video Abstract . CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID NCT03738904. IMPLEMENTACIN DE PROTOCOLO DE RECUPERACIN ACELERADA MULTIMODAL EN CIRUGA ANORRECTAL AMBULATORIA UN ESTUDIO ALEATORIZADO: ANTECEDENTES:Pocos estudios reportan resultados de programas de recuperación acelerada en la cirugía anorrectal ambulatoria. Presumimos que un programa anorrectal ambulatorio de recuperación acelerada con analgesia multimodal puede reducir el uso posoperatorio de opioides.OBJETIVO:Comparar el uso posoperatorio de opioides en pacientes sometidos a cirugía anorrectal ambulatoria que reciben analgesia multimodal versus atención estándar sin analgesia multimodal.DISEÑO:Un estudio prospectivo aleatorizado de pacientes sometidos a cirugía electiva de fístula anal o hemorroides desde septiembre de 2018 hasta mayo de 2022.LUGAR: Hospital universitario urbano.PACIENTES:Adultos de 18 a 70 años sometidos a cirugía electiva de fístula anal o hemorroides desde septiembre de 2018 hasta mayo de 2022.INTERVENCIÓN:Programa de recuperación acelerada multimodal que incluye analgesia no opioide pre y posoperatoria con paracetamol oral, gabapentina y ketoloraco.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue el uso de opioides orales durante la primera semana postoperatoria. Los resultados secundarios incluyeron puntuaciones máximas de dolor y náuseas, eventos adversos e ingresos a la sala de emergencias o al hospital durante los primeros 30 días después de la operación.RESULTADOS:De los 109 pacientes incluidos, 20 se perdieron durante el seguimiento. Los 89 pacientes restantes tenían una mediana de edad de 38 (rango, 20-67) años e incluían 41 (46%) mujeres. No hubo diferencias significativas entre los grupos del protocolo de recuperación acelerada (Grupo E) y del protocolo de recuperación no acelerada (Grupo NE) en términos de características preoperatorias y quirúrgicas. El resultado principal del estudio, el uso de MME oral durante la primera semana, fue significativamente mayor entre los pacientes del grupo NE (79 mg; rango: 0-600) que los pacientes del grupo E (8 mg; rango: 0-390) ( p = 0,002). En el análisis de subgrupos, los pacientes de cirugía de fístula y hemorroides asignados al grupo NE tomaron MME oral significativamente más alto en la primera semana que los pacientes del grupo E. No hubo diferencias significativas en los resultados secundarios.LIMITACIONES:Los pacientes y proveedores no fueron cegados. Nuestros hallazgos se limitan a la cirugía de hemorroides y fístulas y pueden no ser aplicables a otros procedimientos anorrectales.CONCLUSIONES:Se deben utilizar protocolos de recuperación acelerada que incluyan analgesia multimodal en la cirugía electiva de fístula anal y hemorroides para disminuir el uso posoperatorio de opioides. (Traducción- Dr. Francisco M. Abarca-Rendon )CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov ID NCT03738904.

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OBJECTIVE: To observe the clinical efficacy and safety of Yanghe decoction Huacai for the repair of Yin syndrome wounds with slow-healing after anal fistula surgery. METHODS: A total of 120 patients with slow-healing negative wounds with after low-grade anal fistula surgery who met the inclusion criteria were divided into a treatment group and a control group based on a random number table method, with 60 patients in the treatment group and 60 patients in the control group. The treatment group was given Yanghe decoction Huacai in combination with routine treatment; the control group was only given routine treatment, in which the wound surface was disinfected with iodine, and then covered with sterile gauze. The course of treatment in both groups was 10 d. After treatment, the wound secretion score, wound granulation tissue score, the expression levels of basic fibroblast growth factor (bFGF), transforming growth factor ß1 (TGF-ß1), and epidermal growth factor (EGF) in the wound, wound healing time and clinical efficacy were compared. RESULTS: There was no significant difference in age or gender between the two groups (P > 0.05). On the 10th and 15th days after the surgery, the wound secretion scores were higher in the treatment group than in the control group (P < 0.01). Comparing the two groups at the 10th and 15th day after surgery, the granulation tissue growth scores in the treatment group were better than the in control group (P < 0.01). On the 10th and 15th day after operation, the expression levels of bFGF, TGF-ß1 and EGF factors in the treatment group were stronger than those in the control group. The healing time of the wounds in the treatment group was significantly shorter than in the control group (P < 0.01). The clinical efficacy of the two groups after treatment was compared, and the overall efficacy of the treatment group was significantly higher than that of the control group (P < 0.01). CONCLUSIONS: Yanghe decoction Huacai have significant efficacy in the treatment of slow-healing wounds with Yin syndrome after anal fistula surgery. It improves wound secretions, promotes the growth of wound granulation tissue, and shortens wound healing time. Its mechanism of action may be related to the control of wound inflammation. It is related to increasing the expression of bFGF, TGF-ß1 and EGF in wound tissue, and promoting wound angiogenesis and fibroblast proliferation.

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INTRODUCTION: Several studies associate the presence of higher serum concentrations of infliximab (IFX) with fistula healing in perianal Crohn's disease (CD). This study aimed to evaluate serum IFX concentrations in patients with perianal fistulizing CD (PFCD) in the presence or absence of general, clinical, and radiological activities. METHODS: This was a cross-sectional study in patients with PFCD during maintenance treatment with IFX from two centers. Serum IFX concentrations were measured before their next infusion and anal fistulas were evaluated by clinical examination and magnetic resonance imaging (MRI), whenever possible, performed 90 days before or after serum collection. According to clinical scores, radiological activity, and disease markers, patients were classified as in remission or active disease. Mean serum IFX concentrations were compared between the groups. RESULTS: Thirty-eight patients with PFCD were included. Demographic characteristics were similar in patients with remission or active disease. The overall mean serum IFX concentration of the entire sample (n = 38) was 5.21 ± 4.75 µg/mL (median 3.63; IQR 1.44-8.82). Serum IFX levels were 6.25 ± 5.34 µg/mL (median 3.62; IQR 1.95-11.03) in the 23 (60.5%) patients in remission and 3.63 ± 3.24 µg/mL (median 3.63; IQR 1.32-6.43; p = 0.226) in the 15 (39 .5%) who presented active disease. When evaluating general, clinical, and radiological activity of PFCD, and deep remission in isolation, no statistical difference between the groups was observed (p = 0.226, p = 0.418, p = 0.126, and p = 0.232, respectively). The 13 (34.2%) patients with an optimized dose of IFX had significantly higher serum concentrations than the remaining 25 (65.8%) with a standard dose: 8.33 ± 4.41 µg/mL (median 8.36; IQR 3.82-11.20) vs. 3.59 ± 4.13 µg/mL (median 1.97; IQR 1.18-3.85) -p = 0.002. Patients in remission and with an optimized IFX dose had significantly higher serum IFX concentrations than those with a standard dose (p = 0.006), whereas no significant difference was observed among those with active disease (p = 0.083). CONCLUSION: There were no differences in IFX serum concentrations in patients with clinical or radiological active PFCD as compared with those in remission. Patients with an optimized IFX dose had significantly higher serum concentrations than those with a standard dose. Patients in remission and with an optimized IFX dose had significantly higher serum concentrations than those with a standard dose.

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