Validation of a Novel Fecal Incontinence Scale: The Rapid Assessment Fecal Incontinence Score (RAFIS).

OBJECTIVE: The development and validation of a new version of the fecal incontinence (FI) scale "Rapid Assessment Fecal Incontinence Score" (RAFIS) incorporating domains for severity, type of stool loss, and global perception of the effect of incontinence on quality of life (QoL). BACKGROUND: FI negatively impacts on QoL. Currently used incontinence questionnaires have outstanding limitations on the global assessment of the impact of the disease on QoL that patients perceive. We developed a new version of RAFIS with a more complete questionnaire. MATERIALS AND METHODS: A 3-phase study was performed to evaluate the applicability and reliability of our questionnaire as a tool for assessing FI. Our score was completed by 98 patients (78 women; mean age: 57±13 y) who presented with FI and who were referred from 4 colorectal surgery centers. The RAFIS was assessed for internal consistency, test-retest reliability, and sensitivity to change. A multivariate analysis was performed. Comparisons were made with the Wexner Cleveland Clinic Incontinence Score and the Fecal Incontinence Quality of Life Scale. RESULTS: The RAFIS showed good internal consistency and test-retest reliability, differentiating the severity of incontinence but not the etiology. There was a moderate-high correlation between the new scale and the reference scales. Sensitivity to change, compared with the Wexner Score, was moderate. Comparison with established QoL instruments showed a moderate negative correlation. Logistic regression of the RAFIS discriminated between mild and moderate-severe impact on QoL. No correlation was detected with the new score to the presence of an anal sphincter defect or sphincter hypotonia. CONCLUSION: The RAFIS scale is easy to administer and compares well with other validated incontinence instruments.

Feasibility and safety of calcium alginate hydrogel sealant for the treatment of cryptoglandular fistula-in-ano: phase I/IIa clinical trial.

AIM: Complex perianal fistulas pose a challenge to the surgeon since the fistulous tract must be eliminated without impairing continence. Although without strong scientific evidence, some bibliography has demonstrated the efficacy of some sealants in the treatment of anal fistulas. We aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the fistulous tract as treatment for trans-sphincteric cryptoglandular fistulas. METHODS: A prospective, single-centre, case series of this novel technique was conducted in a level 3 Spanish hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. A strict follow-up was performed by an independent surgeon at 1, 3, 6 and 12 months. The main outcome measures were feasibility, safety (number of adverse events) and efficacy of the treatment. RESULTS: Twenty patients were treated. The treatment was performed for all patients. Seven adverse events related to the injection product or the surgical procedure were identified. After a 12-month follow-up, 12 patients were completely cured and eight were not cured, with a greater response in the first 6 months. These findings were confirmed by endoanal ultrasound, with a Cohen's kappa concordance rate of 0.89. No statistically significant differences were observed in pain measured using the visual analogue scale, faecal incontinence measured using the Wexner scoring system, and quality of life analysed by the SF-36 Health Survey. CONCLUSION: The treatment was feasible, safe and with discrete satisfactory healing results. It also demonstrated an acceptable safety profile, without worsening of faecal incontinence, quality of life and pain following treatment.