The effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.
- Conditions
- <p>rectal cancer, bowel symptoms (fecal incontinence, urgency, frequency, fragmented defecation, soiling), Low Anterior Resection Syndrome</p>Rectal cancer10017991
- Registration Number
- NL-OMON26845
- Lead Sponsor
- Research Foundation Flanders
- Brief Summary
The main study of this project was a multicentre randomized controlled trial, investigating the effectiveness of PFMT on low anterior resection syndrome. Initially, 120 patients were foreseen to be included. Eventually, a total of 104 patients was recruited due to time- and COVID-19-restrictions and a lower than predicted drop-out rate. Patients were randomly assigned to an intervention group (n = 50, receiving 12 weeks of PFMT, including pelvic floor muscle exercises, advice, biofeedback, electrical stimulation, bowel training and balloon training) or a control group (n = 54, not receiving PFMT, nor any of the abovementioned treatment modalities). The nine PFMT-sessions were started one month after TME/stoma closure and consisted of a variety of techniques among which pelvic floor muscles exercises, balloon training, biofeedback and evacuation techniques. Regarding bowel symptoms, the LARS- and COREFO- questionnaire, the Numeric Rating Scale (NRS) regarding the subjective bother of bowel symptoms as well as stool diary items were analysed. The SF-12 questionnaire was analysed in relation to the quality of life. All of these outcome measures were assessed at 1, 4, 6 and 12 months after TME/stoma closure. The results demonstrated the effectiveness of PFMT in reducing the proportion of patients with major bowel complaints as per categorized LARS-scores. Stool frequency, incontinence and clustering were also positively influenced by PFMT. Moreover, PFMT ensured a faster recovery process regarding those bowel complaints up to six months after surgery/stoma closure. As regards to quality of life scores, no significant results were found. A 2nd study was conducted to investigate whether bowel symptoms related to LAR for RC could be sufficiently well evaluated by the LARS-questionnaire or the COREFO-questionnaire, compared to the stool diary. Patients were asked to fill out the stool diary and the LARS- and COREFO-questionnaire at 1, 4, 6 and 12 months after TME/stoma closure. Data from a subgroup of 95 patients of the previously mentioned RCT was analysed. Following items were significantly correlated between the LARS-/COREFO-questionnaire and the stool diary: anal incontinence for faeces and frequency of bowel movements. Furthermore, items on soiling were significantly correlated between the COREFO-questionnaire and the stool diary. No significant association was found with the information provided by the stool diary for either questionnaire on items on clustering of bowel movements and urgency. Lastly, overall moderate associations were found between the questionnaires and the stool diary, although the amount of overlapping information was rather limited. Finally the progression of all PA levels (total, sport, occupational and household) was investigated over time, together with the exploration of possible predictive factors for a decrease in those PA levels. Patients were asked to fill out the Flemish Physical Activity Computerized Questionnaire (FPACQ) and the LARS- and COREFO-questionnaire regarding the preoperative period and at 1, 4, 6 and 12 months after TME/stoma closure. Results from the 125 included RC patients showed that total physical activity levels remained significantly lower than preoperative values up to 12 months postoperatively. Furthermore, occupational and sports physical activity levels remained significantly lower until 6 and 4 months postoperative, respectively. Predictive factors for decreased physical activity levels at a specific timepoint were: younger age and no stoma (total physical activity, 1 month), low/mid rectal tumour, no stoma, non-employed status (total, 4 months), higher COREFO-scores (occupational, 4 months) and non-employed status (total, 12 months)."
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 125
- patients planned for a low anterior resection for rectal cancer (TME, total mesorectal excision)
- patients who have an expected survival of at least 1.5 years
- patients who are able to come to the hospital once a week during the complete treatment period (12 weeks)
- patients with a minimal LARS score of 21/42
- having a HARTMANN procedure, abdominiperineal excision or transanal microsurgical resection or sigmoïd resection
- patients with neurological conditions
- patients with cognitive problems
- patients with preoperative fecal incontinence
- patients who have had precious pelvic surgery, previous pelvic radiation or LAR for non-cancer reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>LARS-score, evaluated after 12 weeks (=16 weeks after surgery/closure ileostomy) of pelvic floor muscle training</p>
- Secondary Outcome Measures
Name Time Method <p>colorectal functional outcome questionnaire, bowel diaries, the evolution of physical activity after LAR for rectal cancer, colonic manometry in a subset of patients</p>