There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS. The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
The systematic pelvic floor prehabilitation will start 4 weeks before stoma closure and will include 1 session per week before stoma closure and 1 session per week during 6 weeks following stoma closure. The prehabilitation will be performed according to a predefined protocol based on a biofeedback strategy.
CHU Angers
Angers, France
RECRUITINGAPHP-Hôpital Beaujon
Clichy, France
NOT_YET_RECRUITINGCHD Vendée
La Roche-sur-Yon, France
RECRUITINGClinic Jules Verne
Nantes, France
NOT_YET_RECRUITINGCHU de Poitiers
Poitiers, France
RECRUITINGCHU de Tours
Tours, France
RECRUITINGSeverity of Low Anterior Resection Syndrome Score (LARS score)
questionnaire assessing the five symptoms of the Low Anterior Resection Syndrome : fecal incontinence, gas incontinence, stool frequency, stool clustering and urgency.Total score is reported (minimum score :0 / maximal score : 42)
Time frame: 6 months following stoma closure
Severity of fecal incontinence symptoms evaluated by the dedicated and validated score : Jorge and Wexner score
questionnaire to assess the severity of fecal incontinence symptoms, including stool frequency, stool and gas leakage, social impact and the frequency of pads.a total score is reported (minimum score :0 / maximal score : 20)
Time frame: 6 months following stoma closure
Impact on quality of life evaluated by the dedicated and validated questionnaire
questionnaire quality of life to assess the global quality of life in patients suffering from colorectal cancer Total score is reported
Time frame: 6 months following stoma closure
Morbidity of pelvic floor prehabilitation using biofeedback.
Biofeedback prehabilitation requires a small rectal manometry probe. This outcome will evaluate the morbidity of the rectal introduction of the probe following a colorectal anastomosis.
Time frame: 6 months following stoma closure
Medico-economic impact of pelvic floor prehabilitation including the fecal incontinence related costs
The fecal incontinence related costs will be quantified by the data obtained from the social security insurance and the patients' estimation. The differential benefit of the pelvic floor prehabilitation will be correlated to the quality of life estimated by the QALYS using the EQ-5D questionnaire.
Time frame: 6 months following stoma closure
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