DIPHYSIO study protocol: a pilot multi-centre open-label randomised controlled trial assessing prevention of recurrent DIverticulitis through the use of pelvic floor PHYSIOtherapy

IntroductionDespite the ubiquity of diverticular disease, the options for reducing the risk of recurrent diverticulitis remain limited and the pathogenesis remains incompletely understood. While high intraluminal pressures within the distal colon and rectum have been proposed as a possible association with diverticular disease, studies on this relationship have been few, inconsistent and not generalisable. The investigators of this pilot study propose that the repeated transient high intraluminal pressures generated within the distal colon and rectum due to ineffective defecatory technique may predispose some patients to an increased risk of diverticulosis and diverticulitis. Therefore, by correcting defecatory technique through the implementation of pelvic floor physiotherapy (PFPT), the investigators hypothesise that there would be a reduction in the risk of recurrent diverticulitis. Methods and analysisThis pilot multi-centre open-label randomised controlled trial will be conducted at Queen Elizabeth II Jubilee Hospital (QEII) and Logan Hospital (LGH) in Brisbane, Queensland, Australia. Eligible adult patients admitted with acute diverticulitis will be considered for enrolment and randomised into two groups in a 1:1 allocation ratio. The aim is to recruit 40 patients with 20 patients per group. The control group will receive standard of care dietary advice. The intervention group will receive PFPT as an outpatient within 4 weeks of discharge. The primary endpoint will be the risk of readmission with recurrent diverticulitis within a 12-month follow-up period. Secondary endpoints will be the risk of surgical intervention and/or interventional radiology (IR) procedure in the subgroup of patients readmitted with recurrent diverticulitis. Feasibility outcomes will review patient compliance and completeness of data collection. Results of this trial will inform study design and sample size required in a larger prospective study. Ethics and disseminationApproval was obtained from the Human Research Ethics Committee at the participating centre. Results will be submitted for publication in a peer-reviewed journal. Trial registration numberACTRN126250009274426. STRENGTHS AND LIMITATIONS OF THIS STUDYO_LIThis pilot RCT is the first prospective study to assess the correction of defecatory dysfunction as a method for reducing the risk of recurrent diverticulitis C_LIO_LIA practical design with ease of reproducibility that will inform a larger study adequately powered for hypothesis testing C_LIO_LIOpen-label design poses risk of performance bias C_LIO_LILack of standardisation for pelvic floor physiotherapy interventions may impact generalisability outside of facilities with dedicated pelvic floor units C_LI