Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol

Abstract

IntroductionRadical surgery after a total mesorectal excision (TME) for rectal cancer often results in a significant decrease in the patient’s quality of life, due to functional problems such as bowel, urinary and sexual dysfunction. The effect of pelvic floor muscle training (PFMT) on these symptoms has been scarcely investigated. We hypothesise that the proportion of successful patients will be significantly higher in the intervention group, receiving 12 weeks of PFMT, compared with the control group without treatment. The primary outcome of this trial is the severity of bowel symptoms, measured through the Low Anterior Resection Syndrome questionnaire, 4 months after TME or stoma closure. Secondary outcomes are related to other bowel and urinary symptoms, sexual function, physical activity and quality of life.Methods and analysisThis research protocol describes a multicentre single blind prospective, randomised controlled trial. Since January 2017, patients treated for rectal cancer (n=120) are recruited after TME in three Belgian centres. One month following surgery or, in case of a temporary ileostomy, 1 month after stoma closure, patients are randomly assigned to the intervention group (n=60) or to the control group (n=60). The assessments concern the preoperative period and 1, 4, 6, 12 and 24 months postoperatively.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki. Ethics approval was granted by the local Ethical Committee of the University Hospitals Leuven (s59761) and positive advice from the others centres has been obtained. Dissemination of the results will be accomplished via guidelines and (non-)scientific literature for professionals as well as organisation of patient symposia.Trial registration numberNTR6383.

The Role of Pelvic Floor Muscle Training on Low Anterior Resection Syndrome

“…The study protocol has previously been published. 17 In short, this study was a multicenter, single-blind, prospective RCT. Patients treated for RC were recruited after TME in 3 Belgian hospitals: University Hospitals Leuven, Onze-Lieve-Vrouw (OLV) Hospital in Aalst or General Hospital Groeninge in Kortrijk.…”

“…Exclusion criteria have previously been described. 17 A written consent form was signed by participants before data collection and obtained by the assessor before the first assessment. All data were deidentified and coded with a unique trial identification number.…”

“…The content of the treatment has been described in detail in the published protocol. 17 The control group did not receive any PFMT. During follow-up, every participant was monitored by the department of abdominal surgery, and no adverse events were expected due to PFMT.…”

“…The sessions started with an assessment and evaluation of bowel symptoms with a stool diary, combined with patient education, pelvic floor muscle exercises (focused on strength, endurance, relaxation, proprioception, and coordination), electromyographic-biofeedback/electrical stimulation, and rectal balloon training (improvement of rectal sensation of filling and proper expelling). The content of the treatment has been described in detail in the published protocol 17. The control group did not receive any PFMT.…”

Is evaluation by questionnaires sufficient to cover all aspects of bowel symptoms in rectal cancer patients after low anterior resection?

“…This study was conducted from January 2017 to March 2020 and was part of a larger randomized controlled trial investigating the effect of pelvic floor muscle training on bowel symptoms after RC [ 13 ]. Participants were recruited in Belgium, in the following centres: University Hospitals Leuven, OLV Hospital Aalst or General Hospital Groeninge Kortrijk.…”