Description of a new ultrasound sign to distinguish Crohn's anal fistula from cryptoglandular fistula: The rosary sign.

AIM: Endoanal and endorectal ultrasound are essential diagnostic tools for perianal fistula. Recent studies have examined ultrasound signs that help differentiate cryptoglandular anal fistula from perianal fistulizing Crohn's disease. The main aim of this work was to describe a new ultrasound sign for perianal fistula and to evaluate its ability to differentiate Crohn's disease from cryptoglandular anal fistula. METHOD: This study included 363 patients (113 women; mean age 46.5 ± 14.3 years). Overall, 287 (79.1%) patients had a cryptoglandular perianal fistula and 76 (20.9%) had fistulizing Crohn's disease. All patients underwent three-dimensional anal endosonography for perianal fistula. The reading was carried out by two observers. RESULTS: Observer 1, who was an experienced sonographer and colorectal surgeon, observed the ultrasound sign in 120 patients (33.1%), while observer 2, who was inexperienced, observed it in 129 patients (35.5%). The overall interobserver agreement was 67.22%. The Kappa coefficient measuring interobserver agreement was 0.273 (0.17-0.38). Among those patients with Crohn's disease, 48.68% had the sign and 16% did not (p = 0.001). A logistic regression study showed that the sign was a predictor of Crohn's disease (p = 0.001), with an odds ratio of 2.33 (1.39-3.91). Sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 38.68%, 71.08%, 30.83%, 83.95% and 66.39%, respectively. CONCLUSION: This study provides a new ultrasound sign for perianal fistula (the rosary sign) in patients with Crohn's disease. The sign can be used to differentiate Crohn's disease from other types of fistula. This is useful in the management of patients with anal fistula.

Autologous Platelet-Rich Plasma in the Treatment of Perianal Fistula in Crohn's Disease.

AIM: To assess clinical healing in patients with perianal Crohn's disease with local intrafistular injection of autologous platelet-rich plasma. METHOD: The pilot study was conducted at a single centre between January 2013 and December 2015. Autologous platelet-rich plasma was prepared in platelet-rich and platelet-poor fractions for local intrafistular injection in patients with proven, established perianal Crohn's disease. Patients were permitted biological therapies, and the Perianal Crohn's Disease Activity Index was recorded. Patients were followed for 48 weeks for clinical signs of healing (complete, partial or non-healing), monitoring fistula drainage, closure and epithelialization. RESULTS: The study included 29 patients (19 males; mean age 38 ± 12.8 years) with four exclusions in the operating room because surgery was not indicated and four lost to follow-up. Five adverse events were recorded, with two requiring the drainage of abscess collections. Of the 21 patients assessable at 24 weeks, there was complete healing, partial healing and non-healing in 7 (33.3%), 8 (38.1%) and 6 (28.6%) patients, respectively. By 48 weeks, there was complete healing, partial healing and non-healing in 6 (40%), 6 (40%) and 3 (20%) patients, respectively, with a reduction in the number of visible external fistula openings at both time points (P = 0.021). By the end of the study, there was a higher trend of healing if biological therapies were continued (85.7% with biologics vs. 75% without, P = 0.527), but there were no statistically significant differences and no differences in the Perianal Crohn's Disease Activity Index. CONCLUSION: Autologous platelet-rich plasma is safe in patients with perianal Crohn's disease, with an acceptable healing rate over a medium-term follow-up, particularly if biological therapies are used concomitantly.

Treatment of transsphincteric fistula-in-ano with growth factors from autologous platelets: results of a phase II clinical trial.

PURPOSE: The aim of this paper is to evaluate to the safety, feasibility and efficacy of a novel treatment for transsphincteric cryptoglandular fistula: injection of autologous plasma rich in growth factors (PRGF) into the fistula tract accompanied by sealing using a fibrin plug created from the activated platelet-poor fraction of the same plasma. METHOD: This article is a prospective, phase II clinical trial. The procedure was externally audited. Thirty-six patients diagnosed with transsphincteric fistula-in-ano were included. All patients underwent follow-up examinations at 1 week and again at 3, 6 and 12 months after discharge. Main outcome measures safety (number of adverse events), feasibility and effectiveness of the treatment. RESULTS: A total of 36 patients received the study treatment, with the procedure found to be feasible in all patients. A total of seven adverse events (AE) related to the injected product or surgical procedure were identified in 4 of 36 patients. At the end of the follow-up period (12 months), 33.3% of patients (12/36) had achieved complete fistula healing and 11.1% of patients (4/36) had achieved partial healing. In total, this amounted to 44.4% of patients (16/36) being asymptomatic at final follow-up. In successfully healed patients, a gradual reduction in pain was observed, as measured using a Visual Analog Scale (VAS) (p = 0.0278). Compared to baseline, a significant improvement in Wexner score was seen in patients achieving total or partial healing of the fistula (p = 0.0195). CONCLUSIONS: The study treatment was safe and feasible, with apparently modest efficacy rates. Continence and pain improvement following treatment may be considered predictive factors for healing.

Ultrasonographic evidence of Gatekeeper™ prosthesis migration in patients treated for faecal incontinence: a case series.

BACKGROUND: Faecal incontinence (FI) is both a medical and social problem, with an underestimated incidence. For patients with internal anal sphincter damage, implantation of biomaterial in the anal canal is a recognised treatment option. One such material, Gatekeeper™, has previously shown promising short- and medium-term results without any major complications, including displacement. The main aim of the present study is to assess the degree to which displacement of Gatekeeper prostheses may occur and to determine whether this is associated with patient outcomes. METHODS: Seven patients (six females) with a mean age of 55.6 years [50.5-57.2] and a mean FI duration of 6 ± 2 years were prospectively enrolled in the study. Each subject was anaesthetised and underwent implantation of six prostheses in the intersphincteric region, guided by endoanal 3D ultrasound (3D-EAU). Follow-up was performed at post-interventional months 1, 3, and 12 (median 12 ± 4 months), during which data were obtained from a defaecation diary, Wexner scale assessment, anorectal manometry (ARM), 3D-EAU, and a health status and quality of life questionnaire (FIQL). RESULTS: At 3-month follow-up, 3D-EAU revealed displacement of 24/42 prostheses in 5/7 patients. Of these, 15 had migrated to the lower portion and 9 to the upper portion of the anal canal and rectum. Despite this migration, treatment was considered successful in 3/7 patients. In one patient, it was necessary to remove a prosthesis due to spontaneous extrusion. CONCLUSIONS: We have shown that displacement of the Gatekeeper™ prosthesis occurs, but is not associated with poorer clinical outcomes.

Is the interval from surgery to ileostomy closure a risk factor for low anterior resection syndrome?

AIM: Low anterior resection syndrome (LARS) comprises a collection of symptoms affecting patients after restorative surgery for rectal cancer. The aim of the present study was to analyse the incidence of LARS in patients undergoing rectal cancer surgery with and without subsequent ileostomy and to determine whether the interval to ileostomy closure is a factor associated with its occurrence. METHOD: All patients undergoing curative anterior resection for rectal cancer from 2008 to 2012 in our institution were included in the study. They were divided into two groups according to whether or not a defunctioning ileostomy had been performed. Patients were assessed for LARS at a median interval of 23.60 ± 16.73 (12-48) months from anterior resection in those who did not have an ileostomy and at an interval of 11.31 ± 14.24 (12-60) months from closure of the ileostomy in those who did. They underwent a structured telephone interview based on a validated LARS score questionnaire. Univariate and multivariate analysis was carried out to assess possible associations between LARS and the variables studied. RESULTS: There were 150 patients (93 men) of whom 54.7% had no evidence of LARS, 17.3% had minor symptoms and 28% major symptoms of LARS. Univariate analysis showed that male gender, the presence of a temporary ileostomy and neoadjuvant therapy were predisposing factors for LARS. The interval from construction of the ileostomy to its closure did not appear to be a factor associated with LARS. In multivariate analysis, male gender and preoperative neoadjuvant therapy were significant predisposing factors for LARS. CONCLUSION: Male gender and preoperative neoadjuvant therapy are risk factors for LARS. The presence of ileostomy or time to ileostomy closure is not associated with the development of this syndrome.

Effectiveness of a three-dimensional anorectal ultrasound in perianal Crohn's disease: incompatibility with clinical and surgical examinations.

PURPOSE: We have correlated the 3D anorectal ultrasound (3D ARU) findings with clinical examination and the surgical findings and examined its capacity to provide ancillary information, which potentially alters patient management. PATIENTS AND METHODS: This is a prospective analysis conducted at a tertiary academic hospital. A total of 95 patients were included. We screened for sphincter defects and the presence of perianal Crohn's disease (PACD)-related lesions. RESULTS: We performed 150 3D ARUs. Exploratory ultrasound coincided with the rationale for diagnosis in 67.7% of cases, and fistulae were detected in 79% of cases where there was clinical suspicion. Fistulae were associated with abscesses in 29 cases, and isolated abscesses were identified in 19 cases (17.7%), only 12 of which (63.2%) were clinically suspected. Sphincter defects were observed in 15 cases with 7 cases (77.8%) presenting with clinical fecal incontinence. The operative findings coincided with ultrasonographic findings in 81.3% of the analyzed cases. The inter-observer variability of endosonographic classification resulted in a kappa score of 0.86. Ultrasonographic data altered the therapeutic plan of management in 73 cases (48.6%). CONCLUSIONS: Three-dimensional ARU is accurate in the diagnosis of fistula type in PACD and in the delineation of ancillary suspected and unsuspected abscess collections. Its use impacts therapeutic management in about half the cases examined. A new ultrasonographic-based PACD classification system is presented which has high inter-observer agreement but which requires future prospective validation in clinical PACD patients.

Percutaneous neuromodulation of the posterior tibial nerve for the treatment of faecal incontinence - mid-term results: is retreatment required?

AIM: Posterior tibial nerve stimulation (PTNS) has emerged in recent years as a therapy for faecal incontinence. Its long-term effectiveness is yet to be established, along with what the form of retreatment should be in the event of loss of effectiveness. The present study aimed to establish the mid-term results to identify the proportion of patients who may need further treatment, and if so when. METHOD: A prospective study including 30 patients was conducted at an academic hospital. The patients underwent 12 weekly outpatient treatment sessions, each lasting 30 min (first PTNS phase). Neuromodulation was discontinued in those patients who did not have a 40% decrease in their pretreatment Wexner score. Patients having a better than 40% response were offered another 12-week course of complete treatment (second PTNS phase), following which they received no further PTNS treatment (phase without PTNS) but were assessed at 6 months and 2 years. RESULTS: All patients finished the first phase and 22/30 patients continued to the second phase. During this phase 11 patients showed an improved Wexner score (baseline/first phase/second phase: 14.3 ± 4.2 vs 9.9 ± 5.4 vs 6.8 ± 5.4). After a 6-month period without any treatment, the score was still improved in 11/30 patients (9.1 ± 6.2). At 2 years there was improvement in 16/30 patients (8.8 ± 7.1). There was a significant improvement in three variables of the quality of life questionnaire: lifestyle, coping behaviour and embarrassment. CONCLUSION: The response to first and second phase PTNS was maintained for up to 2 years. Retreatment was not required in about half of patients, even when they had finished the treatment 6 months or 2 years previously.