Chapter 5 128 a pelvic floor physical therapist, will approach the patient and inform him/her about the study. It is the responsibility of the surgeon and the PI to provide the patient with detailed information, both orally and writing, about the aims and design of the study, as well as the medical procedures involved. If necessary, the patient will have the opportunity to ask all possible questions and receive additional information throughout enrolment in the study. If eligible, the PI will provide the patient with an information letter and informed consent form, explaining the purpose of the study, study design, benefits, and patient risks. According to Good Clinical Practice, a patient is asked for formal consent prior to participation. Patients who decide to participate will bring the signed consent form at first visit with the PI. The PI is assigned for inclusion and informed consent and will be responsible for storing the signed informed consent forms. For those patients who do not consent to participate, the reason(s) for declining will be anonymously recorded in a database. Follow-up procedure Follow-up for all patients will consist of an appointment with the surgeon and PI, at 8 weeks from baseline. Clinical examination will be provided through inspection and digital rectal examination to investigate the improvement of healing of the fissure and pelvic floor function. Patients are requested to fill in the validated questionnaires at this timepoint. Patients who were allocated to postponed PFPT will start their treatment after this first follow-up assessment. Patients from both groups will visit the surgeon and PI and fill in the questionnaires at 20 weeks and 1-year follow-up. Withdrawal Patients can leave the study at any time for any reason without any consequences. This will have no consequences for their further treatment. The PI or surgeon can decide to withdraw a patient from the study for urgent medical reasons. Patients will not be replaced in this study after withdrawal. Randomization and blinding After obtaining fully written informed consent, patients will be randomly assigned to be treated with PFPT or assigned to a control group which will receive postponed PFPT (1:1 allocation, random block sizes of 4, 6 and 8). The randomization will be computer generated using Castor EDC (www.castoredc.com). A unique record number will be generated, and the allocation will be disclosed. The PI will not be able to access
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