5 Study protocol for a randomized controlled trial: PAF-study 125 Introduction A chronic anal fissure (CAF) is a longitudinal tear in the anoderm with one or more signs of chronicity including hypertrophied anal papilla, sentinel tag and exposed internal sphincter muscle with symptoms present for longer than 4-6 weeks.1,2 CAF is a common cause of severe anorectal pain in adults, with a high incidence rate3 and negatively impacts quality of life.4,5 Patients with CAF usually experience anal pain, during and immediately after defecation, which may last for several hours. The pathophysiology of CAF is not fully understood, and treatment varies. Conservative management consists of lifestyle advice, high fiber diet and relaxation of the internal sphincter tone with ointment, thus improving blood flow and symptom relief.2,6 When this conservative treatment fails, the next step can be botulinum toxin injections or lateral internal sphincterotomy (LIS). Botulinum is used as an effective treatment modality for anal fissure. It is considered as a minimal invasive procedure with minor adverse effects but has a recurrence rate of 41,7%.7 The cure rate of LIS is higher than botulinum toxin and has a recurrence rate of 6.9%,7 however there is a potential risk of incontinence.7-10 Nevertheless, LIS is the golden standard of care for surgical treatment of CAF.6,11 A proportion of patients with CAF have concomitant pelvic floor dyssynergia.12 Dyssynergia typically present with defecation difficulties consisting of prolonged straining, frequent attempts of evacuation, a feeling of incomplete evacuation and anorectal pain because of incomplete relaxation of the puborectalis muscle.13,14 Anorectal pain could also result in increased tone of the pelvic floor muscles, and this is typically associated with symptoms of post-defecatory pain which can last for hours.15,16 Dyssynergia and/or increased tone of the pelvic floor may probably lead to a vicious circle of pain and delayed healing.17 These pelvic floor dysfunctions can effectively be treated with pelvic floor physical therapy (PFPT) including biofeedback therapy and/or neuromuscular electrical stimulation18-24 and are recommended in current clinical guidelines.25,26 In addition, PFPT including biofeedback therapy and/or neuromuscular electrical stimulation is a minimal invasive treatment with a low risk of adverse events.25,27-29 CAF is a debilitating and bothersome condition, particularly because of its recurrent nature. Prolonged persistence of symptoms and recurrence indicate that present treatment modalities are not always sufficient. Currently, there is a gap in treatment modalities between conservative management and surgery. Therefore, we aim to provide a management protocol for PFPT to bridge this gap. We hypothesise that treatment with PFPT in patients with CAF and concomitant pelvic floor dysfunction will result in improvement of pelvic floor muscle tone and function, pain, healing of the fissure, quality of life and complaint reduction.
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