Chapter 5 136 Data category Information Study type Interventional Allocation: randomized Intervention model: parallel assignment Sequence generation: 1:1 allocation, random block sizes of 4,6 and 8 No blinding: the principal investigator, collaborating pelvic floor physical therapists, patients Blinding: surgeon Date of first enrolment 10 December 2018 Target sample size 140 Recruitment status Complete Primary outcome(s) Tone at rest (µV) during surface electromyographic registration of the pelvic floor before and after therapy. Key secondary outcomes Prevalence of pelvic floor dysfunction; -pelvic floor muscle function; -VAS-pain; -healing of the fissure (complete re-epithelisation and absence of pain); -quality of life (RAND-36); - complaint reduction with proctology specific patient reported outcome measurement (Proctoprom) Appendix 1. Continued
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