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van CCT (UK)

van CCT (UK)

The effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.

- candidate number26507
- NTR NumberNTR6383
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jan-2017
- Secondary IDss59761 Ethics Committee
- Public TitleThe effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.
- Scientific TitleThe effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.
- hypothesisThe proportion of successful patients, defined as an improvement in LARS category, will be 25% larger in the experimental group than in the control group (in which 10 % improvement is assumed).
- Healt Condition(s) or Problem(s) studiedRectal cancer, Pelvic floor muscles, Rectal resection for rectal carcinoma
- Inclusion criteria- 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
- Exclusion criteria- having a HARTMANN procedure, abdominiperineal excision or transanal microsurgical resection or sigmo´d 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2016
- planned closingdate31-dec-2020
- Target number of participants120
- InterventionsControl group + intervention group: LARS-score, Colorectal Functional Outcome Questionnaire, International Consulation on Incontinence Questionnaire, Female Sexual Function Index/ Interternational Index of Erectile Function, Flemish Physical Activity Questionnaire, Numeric Rating Scale, Bowel Diary, Bladder Diary, 1 hour Pad test, Evaluation pelvic floor muscles (tone, strength, endurance)
Intervention group: pelvic floor muscle training (9 times in 12 weeks)
High Resolution Pan Colonic manometry in a subset of patients with remaining symptoms
- Primary outcomeLARS-score, evaluated after 12 weeks (=16 weeks after surgery/closure ileostomy) of pelvic floor muscle training
- Secondary outcomecolorectal functional outcome questionnaire, bowel diaries, the evolution of physical activity after LAR for rectal cancer, colonic manometry in a subset of patients
- TimepointsPreoperative assessment of bowel symptoms, urinary symptoms, sexual symptoms, physical activity
Assessment at 4 weeks after surgery/closure ileostomy (start PFMT for the intervention group) and at 16 weeks (primary endpoint) after surgery/closure ileostomy (end PFMT): bowel symptoms, urinary symptoms, sexual symptoms, physical activity, muscle tone/force/endurance pelvic floor muscles
Follow-up assessments after 6 and 12 months: bowel symptoms, urinary symptoms, sexual symptoms, physical activity, tone/strength/endurance pelvic floor muscles
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Katholieke Universiteit Leuven, UZ Leuven
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summarySince several years, low anterior resection, with total mesorectal excision and preservation of the autonomic nerves of the pelvis has become the gold standard for rectal cancer surgery. However, this surgery affects bowel function in 60-90% of patients. These symptoms are referred to as the low anterior resection syndrome and is associated with a large negative impact on quality of life . Currently, patients only receive some anti-diarrheal medication, diet advice or the advice to wait for spontaneous improvement. Although pelvic floor muscle training is highly recommended in the treatment of bowel problems in non-cancer populations, there is still no concensus about its effectiveness in rectal cancer patients. In this research we aim (1) to evaluate if patients, who receive 12 weeks of intensive pelvic floor muscle training, have less LAS symptoms then patients who had no treatment; (2) to investigate the effect of a temporary ileostomy on LAR symptoms; (3) to assess propulsive colonic contractions and the effect of hindgut denervation on the presence of coordinated proximal to distal contractions; (4) to study the influence of LAR for rectal cancer on all physical activity levels
- Main changes (audit trail)
- RECORD23-jan-2017 - 21-jun-2017

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