Chapter 5 126 Material and Methods Objectives Primary Objective: To establish the efficacy and effectiveness of treatment of CAF and pelvic floor dysfunction with PFPT including surface electromyography (s-EMG)- biofeedback. Secondary objectives: - Prevalence of pelvic floor dysfunction in chronic anal fissure; - relation between CAF and other pelvic floor dysfunctions; - pain reports; - healing of the fissure; - quality of life; - complaint reduction with a proctology specific patient reported outcome measurement. Study design The PAF-study is a single-centre, parallel, randomized controlled trial (RCT). This superiority trial is designed to detect a difference of PFPT including biofeedback and no PFPT at first follow-up. The overall design is shown in figure 1. The design involves allocation of all appropriate consecutive patients with CAF and pelvic floor dysfunction. Eligible patients will be randomly assigned to an intervention group, which will receive 8 weeks of PFPT or assigned to a control group which will receive postponed PFPT. A complete list of items from the World Health Organization Trial Registration Data Set is provided in Appendix 1. Eligibility The study population will consist of all patients >18 years old, presenting with CAF and pelvic floor dysfunction. Inclusion criteria: - Complaints of more than 6 weeks and all patients failed conservative treatment with ointment, fibers and/or laxatives - Sufficient understanding of the Dutch written language (reading and writing) - Able to complete online questionnaires - Written informed consent Exclusion criteria: - Presenting an abscess or fistula - Crohn’s disease or ulcerative colitis - Anorectal malignancy - Previous rectal radiation - Pregnancy
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