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.