An interventional study of Pelvic floor prehabilitation in Rectal Cancer, sponsored by Nantes University Hospital. Terminated at 6 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
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.
1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 120 is above the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
The systematic pelvic floor prehabilitation will start 4 weeks before stoma closure and will include 1 sessions per week before stoma closure and 1 sessions per week during 6 weeks following stoma closure. Complementary sessions are allowed if necessary.
Procedure: Pelvic floor prehabilitation
No pelvic floor prehabilitation will be proposed before stoma closure. The pelvic floor prehabilitation will be proposed to patients suffering from LARS
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.
Also known as: Preoperative rehabilitation
Severity 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
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital