The 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).
ID
Source
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Health condition
rectal cancer, bowel symptoms (fecal incontinence, urgency, frequency, fragmented defecation, soiling), Low Anterior Resection Syndrome
Research involving
Sponsors and support
Intervention
- Movement therapy
Outcome measures
Primary outcome
LARS-score, evaluated after 12 weeks (=16 weeks after surgery/closure ileostomy) of pelvic floor muscle training
Secondary outcome
colorectal functional outcome questionnaire, bowel diaries, the evolution of physical activity after LAR for rectal cancer, colonic manometry in a subset of patients
Background summary
Since 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
Study objective
The 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).
Study design
"Preoperative 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 Study outcomes: Control 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) "
Intervention
pelvic floor muscle training
Inge Geraerts
Katholieke Universiteit Leuven
Faculteit Bewegings- en Revalidatiewetenschappen
Tervuursevest 101
Leuven 3001
Belgium
+32 16329120
inge.geraerts@faber.kuleuven.be
Inge Geraerts
Katholieke Universiteit Leuven
Faculteit Bewegings- en Revalidatiewetenschappen
Tervuursevest 101
Leuven 3001
Belgium
+32 16329120
inge.geraerts@faber.kuleuven.be
Age
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 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6227 |
| NTR-old | NTR6383 |
| Other | Number Ethical Committee of University Hospitals Leuven S59761 |
Summary results
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)."